Arcos Modular Revision Hip SystemRecalls & reported problems across all models
Biomet Orthopedics, LLC · 71 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 191
- Deaths reported
- 2
- Injuries reported
- 158
- Recalls
- 19
We found 71 models of Arcos Modular Revision Hip System by Biomet Orthopedics, LLC in the FDA's device registry (GUDID). Together they are named in 191 adverse event reports in the FDA's MAUDE database, received between Nov 4, 2019 and Sep 28, 2026 — classified as 2 deaths, 158 injuries, 31 malfunctions.
The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (24 reports).
19 FDA recall records name at least one of these models by its device identifier.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Arcos Modular Revision Hip System recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Jan 7, 2022Terminated
The products in scope underwent an incorrect rework operation for the porous plasma sprayed coating. Internal testing indicated that the parts may not have sufficient adhesion strength. The scope was identified to be all lots that were porous plasma coated or recoated at a vendor that were then reworked through the internal waterjet rework process. The waterjet rework process for porous plasma coating is not validated for products that were coated at a vendor.
Z-0670-2022 · Root cause: Process control · Recall details · FDA record ↗
- Jun 2, 2021Terminated
Arcos Proximal Cone Bodies could potentially exhibit chatter in the inner taper fretting corrosion and device failure in vivo leading to surgical intervention
Z-2275-2021 · Root cause: Process control · Recall details · FDA record ↗
- Jun 2, 2021Terminated
Arcos Proximal Cone Bodies could potentially exhibit chatter in the inner taper fretting corrosion and device failure in vivo leading to surgical intervention
Z-2274-2021 · Root cause: Process control · Recall details · FDA record ↗
- Jun 2, 2021Terminated
Arcos Proximal Cone Bodies could potentially exhibit chatter in the inner taper fretting corrosion and device failure in vivo leading to surgical intervention
Z-2273-2021 · Root cause: Process control · Recall details · FDA record ↗
- Jun 2, 2021Terminated
Arcos Proximal Cone Bodies could potentially exhibit chatter in the inner taper fretting corrosion and device failure in vivo leading to surgical intervention
Z-2272-2021 · Root cause: Process control · Recall details · FDA record ↗
- Jun 2, 2021Terminated
Arcos Proximal Cone Bodies could potentially exhibit chatter in the inner taper fretting corrosion and device failure in vivo leading to surgical intervention
Z-2271-2021 · Root cause: Process control · Recall details · FDA record ↗
- Jun 2, 2021Terminated
Arcos Proximal Cone Bodies could potentially exhibit chatter in the inner taper fretting corrosion and device failure in vivo leading to surgical intervention
Z-2270-2021 · Root cause: Process control · Recall details · FDA record ↗
- Jun 2, 2021Terminated
Arcos Proximal Cone Bodies could potentially exhibit chatter in the inner taper fretting corrosion and device failure in vivo leading to surgical intervention
Z-2269-2021 · Root cause: Process control · Recall details · FDA record ↗
- Jun 2, 2021Terminated
Arcos Proximal Cone Bodies could potentially exhibit chatter in the inner taper fretting corrosion and device failure in vivo leading to surgical intervention
Z-2268-2021 · Root cause: Process control · Recall details · FDA record ↗
- Jun 2, 2021Terminated
Arcos Proximal Cone Bodies could potentially exhibit chatter in the inner taper fretting corrosion and device failure in vivo leading to surgical intervention
Z-2267-2021 · Root cause: Process control · Recall details · FDA record ↗
- Jun 2, 2021Terminated
Arcos Proximal Cone Bodies could potentially exhibit chatter in the inner taper fretting corrosion and device failure in vivo leading to surgical intervention
Z-2266-2021 · Root cause: Process control · Recall details · FDA record ↗
- Jun 2, 2021Terminated
Arcos Proximal Cone Bodies could potentially exhibit chatter in the inner taper fretting corrosion and device failure in vivo leading to surgical intervention
Z-2265-2021 · Root cause: Process control · Recall details · FDA record ↗
- Jun 2, 2021Terminated
Arcos Proximal Cone Bodies could potentially exhibit chatter in the inner taper fretting corrosion and device failure in vivo leading to surgical intervention
Z-2264-2021 · Root cause: Process control · Recall details · FDA record ↗
- Jun 2, 2021Terminated
Arcos Proximal Cone Bodies could potentially exhibit chatter in the inner taper fretting corrosion and device failure in vivo leading to surgical intervention
Z-2263-2021 · Root cause: Process control · Recall details · FDA record ↗
- Jun 2, 2021Terminated
Arcos Proximal Cone Bodies could potentially exhibit chatter in the inner taper fretting corrosion and device failure in vivo leading to surgical intervention
Z-2262-2021 · Root cause: Process control · Recall details · FDA record ↗
- Jun 2, 2021Terminated
Arcos Proximal Cone Bodies could potentially exhibit chatter in the inner taper fretting corrosion and device failure in vivo leading to surgical intervention
Z-2261-2021 · Root cause: Process control · Recall details · FDA record ↗
- Jun 2, 2021Terminated
Arcos Proximal Cone Bodies could potentially exhibit chatter in the inner taper fretting corrosion and device failure in vivo leading to surgical intervention
Z-2260-2021 · Root cause: Process control · Recall details · FDA record ↗
- Jun 2, 2021Terminated
Arcos Proximal Cone Bodies could potentially exhibit chatter in the inner taper fretting corrosion and device failure in vivo leading to surgical intervention
Z-2259-2021 · Root cause: Process control · Recall details · FDA record ↗
- Jun 8, 2018Terminated
Two lots of the Echo BI-Metric Hip Stem and ARCOS Modular Revision Hip Stem may have been comingled. Potential health consequences include extension of surgery time to find a replacement component.
Z-2820-2018 · Root cause: Process control · Recall details · FDA record ↗
Most reported Arcos Modular Revision Hip System problems
Device problems
- Adverse Event Without Identified Device or Use Problem68
- Loosening of Implant Not Related to Bone-Ingrowth24
- Migration22
- Fracture16
- Separation Failure11
- Difficult to Insert8
- Inadequacy of Device Shape and/or Size8
- Detachment of Device or Device Component7
Patient problems
- Failure of Implant35
- No Clinical Signs, Symptoms or Conditions32
- Insufficient Information27
- Bone Fracture(s)23
- Pain21
- Unspecified Infection18
- Aseptic loosening12
- Joint Dislocation12
Arcos Modular Revision Hip System models
71 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Arcos Modular Revision Hip System 11-301301Prosthesis, hip, semi-constrained, metal/polymer, cemented2 recalls8 reports
- Arcos Modular Revision Hip System 11-301310Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous cemented, osteophilic finish1 recall9 reports
- Arcos Modular Revision Hip System 11-301321PROSTHESIS, ELBOW, CONSTRAINED, CEMENTED1 recall7 reports
- Arcos Modular Revision Hip System 11-301300Prosthesis, hip, semi-constrained, metal/polymer, cemented1 recall7 reports
- Arcos Modular Revision Hip System 11-301311Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented1 recall5 reports
- Arcos Modular Revision Hip System 11-301302PROSTHESIS, ELBOW, CONSTRAINED, CEMENTED1 recall5 reports
- Arcos Modular Revision Hip System 11-301312Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented1 recall4 reports
- Arcos Modular Revision Hip System 11-300814Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented1 recall4 reports
- Arcos Modular Revision Hip System 11-301342Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous cemented, osteophilic finish1 recall4 reports
- Arcos Modular Revision Hip System 11-301331Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented1 recall4 reports
- Arcos Modular Revision Hip System 11-301333Prosthesis, hip, semi-constrained, metal/polymer, cemented1 recall3 reports
- Arcos Modular Revision Hip System 11-301322Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate1 recall2 reports
- Arcos Modular Revision Hip System 11-301315Prosthesis, hip, constrained, cemented or uncemented, metal/polymer1 recall2 reports
- Arcos Modular Revision Hip System 11-301314Prosthesis, hip, semi-constrained, metal/polymer, cemented1 recall1 report
- Arcos Modular Revision Hip System 11-301343PROSTHESIS, ELBOW, CONSTRAINED, CEMENTED1 recall1 report
- Arcos Modular Revision Hip System 11-301335Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented1 recall1 report
- Arcos Modular Revision Hip System 11-301354Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented1 recall0 reports
- Arcos Modular Revision Hip System 11-301325PROSTHESIS, ELBOW, CONSTRAINED, CEMENTED1 recall0 reports
- Arcos Modular Revision Hip System 11-300816Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented9 reports
- Arcos Modular Revision Hip System 11-301303Prosthesis, hip, constrained, cemented or uncemented, metal/polymer8 reports
- Arcos Modular Revision Hip System 11-300815Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate7 reports
- Arcos Modular Revision Hip System 11-300817Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous cemented, osteophilic finish6 reports
- Arcos Modular Revision Hip System 11-301323Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented5 reports
- Arcos Modular Revision Hip System 11-301815Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate5 reports
- Arcos Modular Revision Hip System 11-300915PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED1 death5 reports
- Arcos Modular Revision Hip System 11-300818Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate4 reports
- Arcos Modular Revision Hip System 11-300819Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented4 reports
- Arcos Modular Revision Hip System 11-300917Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented4 reports
- Arcos Modular Revision Hip System 11-300812Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate3 reports
- Arcos Modular Revision Hip System 11-301352Prosthesis, hip, constrained, cemented or uncemented, metal/polymer1 death3 reports
- Arcos® Modular Revision Hip System 11-302130Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented3 reports
- Arcos® Modular Revision Hip System 11-302138Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous cemented, osteophilic finish3 reports
- Arcos Modular Revision Hip System 11-301353PROSTHESIS, ELBOW, CONSTRAINED, CEMENTED3 reports
- Arcos Modular Revision Hip System 11-300813Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate3 reports
- Arcos Modular Revision Hip System 11-301313Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous cemented, osteophilic finish2 reports
- Arcos Modular Revision Hip System 11-300820Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented2 reports
- Arcos Modular Revision Hip System 11-302101PROSTHESIS, ELBOW, CONSTRAINED, CEMENTED2 reports
- Arcos Modular Revision Hip System 11-300916Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous cemented, osteophilic finish2 reports
- Arcos Modular Revision Hip System 11-300912PROSTHESIS, ELBOW, CONSTRAINED, CEMENTED2 reports
- Arcos Modular Revision Hip System 11-301024Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous cemented, osteophilic finish2 reports
- Arcos Modular Revision Hip System 11-300914PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED2 reports
- Arcos Modular Revision Hip System 11-301916Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate2 reports
- Arcos Modular Revision Hip System 11-301015Prosthesis, hip, semi-constrained, metal/polymer, cemented2 reports
- Arcos Modular Revision Hip System 11-301013Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous cemented, osteophilic finish2 reports
- Arcos Modular Revision Hip System 11-300913Prosthesis, hip, semi-constrained, metal/polymer, cemented2 reports
- ARCOS MODULAR REVISION HIP SYSTEM 11-302109PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED2 reports
- Arcos Modular Revision Hip System 11-301101PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED1 report
- Arcos Modular Revision Hip System 11-302015Prosthesis, hip, semi-constrained (metal cemented acetabular component)1 report
- Arcos Modular Revision Hip System 11-301620Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate1 report
- Arcos Modular Revision Hip System 11-301344Prosthesis, hip, semi-constrained, metal/polymer, cemented1 report
- Arcos Modular Revision Hip System 11-301414Prosthesis, hip, semi-constrained, metal/polymer, cemented1 report
- Arcos Modular Revision Hip System 11-301351PROSTHESIS, ELBOW, CONSTRAINED, CEMENTED1 report
- Arcos Modular Revision Hip System 11-300822Prosthesis, hip, constrained, cemented or uncemented, metal/polymer1 report
- Arcos Modular Revision Hip System 11-302102PROSTHESIS, ELBOW, CONSTRAINED, CEMENTED1 report
- Arcos Modular Revision Hip System 11-300824Prosthesis, hip, semi-constrained, metal/polymer, cemented1 report
- Arcos Modular Revision Hip System 11-300918Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented1 report
- Arcos® Modular Revision Hip System 11-302134Prosthesis, hip, constrained, cemented or uncemented, metal/polymer1 report
- Arcos® Modular Revision Hip System 11-302128PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED1 report
- Arcos Modular Revision Hip System 11-301014Prosthesis, hip, semi-constrained, metal/polymer, cemented1 report
- Arcos Modular Revision Hip System 11-301016Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous cemented, osteophilic finish1 report
- Arcos Modular Revision Hip System 11-301341PROSTHESIS, ELBOW, CONSTRAINED, CEMENTED1 report
- Arcos Modular Revision Hip System 11-301818Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented1 report
- Arcos Modular Revision Hip System 11-300615PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED1 report
- Arcos Modular Revision Hip System 11-300626Prosthesis, hip, semi-constrained, metal/polymer, cemented1 report
- Arcos Modular Revision Hip System 11-301017Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented1 report
- Arcos Modular Revision Hip System 11-300919Prosthesis, hip, semi-constrained, metal/polymer, cemented1 report
- Arcos Modular Revision Hip System 11-301305PROSTHESIS, ELBOW, CONSTRAINED, CEMENTED1 report
- Arcos Modular Revision Hip System 11-301723Prosthesis, hip, semi-constrained, metal/polymer, cemented1 report
- Arcos Modular Revision Hip System 11-300925PROSTHESIS, ELBOW, CONSTRAINED, CEMENTED1 report
- Arcos Modular Revision Hip System 11-300929Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented1 report
- Arcos Modular Revision Hip System 11-300921Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate1 report
Recent Arcos Modular Revision Hip System adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjurySep 28, 2026Loosening of Implant Not Related to Bone-Ingrowth
Patient problems: Aseptic loosening
MAUDE report 50926656 ↗InjuryAug 18, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the patient underwent removal of the trochanteric claw and bolt. Surgeon stated user error of original positioning of the trochanteric claw (different surgeon who implanted claw/bolt), which required removal due to poor positioning. Revision surgery involved removal of claw and bolt, washout and closing.The claw was firmly stuck onto the bone, and was levered out with an osteotome after removing the bolt. There was no issue with the implants themselves. Overall, the surgery was approximately fifteen (15) minutes.Attempts have been made and additional information on the reported event is unavailable at this time.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50305771 ↗InjuryAug 18, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the patient underwent removal of the trochanteric claw and bolt. Surgeon stated user error of original positioning of the trochanteric claw (different surgeon who implanted claw/bolt), which required removal due to poor positioning. Revision surgery involved removal of claw and bolt, washout and closing.The claw was firmly stuck onto the bone, and was levered out with an osteotome after removing the bolt. There was no issue with the implants themselves. Overall, the surgery was approximately fifteen (15) minutes.Attempts have been made and additional information on the reported event is unavailable at this time.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50305769 ↗InjuryAug 10, 2026Mechanical Problem
It was reported that approximately two months post-implantation, the patient underwent a hip revision due to the patient being unable to internally rotate their foot. There was a suspected failure of the taper junction or proximal body locking screw. Attempts have been made and no further information has been provided.
Patient problems: Loss of Range of Motion
MAUDE report 50193256 ↗InjuryJul 9, 2026Device Dislodged or Dislocated
IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL HIP PROCEDURE. DURING THE PROCEDURE, A TRIFLANGE WAS IMPLANTED WITH ZIMMER BIOMET LINER AND COMPETITOR STEM. PT HAD UNKNOWN MEDICAL EPISODE CAUSING HIM TO DISLOCATE HIP. SURGEON ATTEMPTED REDUCTION AND BROKE PT FEMUR IN THE PROCESS. THE PATIENT WAS REVISED APPROXIMATE 2 MONTHS POST-IMPLANTATION DUE TO THE DISLOCATION AND BONE FRACTURE. A CONSTRAINED LINER AND ARCOS STEM WAS IMPLANTED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: Bone Fracture(s); Joint Dislocation
MAUDE report 25761549 ↗InjuryJul 8, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT APPROXIMATELY SIX WEEKS POST-IMPLANTATION, THE PATIENT UNDERWENT A HIP REVISION DUE TO FRACTURE. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: Periprosthetic fracture
MAUDE report 25752724 ↗InjuryJun 12, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT DURING IMPLANTATION OF THE NEW PROSTHESIS, A DISTAL FEMORAL FRACTURE OCCURRED, AND THE CANAL WAS STABILIZED BEFORE PROCEEDING. THE PATIENT SUSTAINED AN INTRA-OPERATIVE DISTAL FEMORAL FRACTURE THAT WAS TREATED WITH CABLE FIXATION. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: Periprosthetic fracture
MAUDE report 25484651 ↗InjuryMay 28, 2026Loosening of Implant Not Related to Bone-Ingrowth
IT WAS REPORTED THAT THE PATIENT UNDERWENT A HIP REVISION APPROXIMATELY TWO MONTHS POST-IMPLANTATION. IT WAS NOTED, THE PROXIMAL BODY OR STEM SEEMS TO HAVE ROTATED, PLAN WAS TO REVISE PROXIMAL BODY HOWEVER THE PROXIMAL BODY COULD NOT BE MOVED, AND THE SCREW SEEMED CROSS THREADED, SO SURGEON REMOVED ENTIRE COMPONENT. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; TO DATE NO ADDITIONAL INFORMATION OR PRODUCT HAS BEEN RECEIVED.
Patient problems: Aseptic loosening
MAUDE report 25315618 ↗InjuryMay 28, 2026Loosening of Implant Not Related to Bone-Ingrowth; Damaged Thread
IT WAS REPORTED THAT THE PATIENT UNDERWENT A HIP REVISION APPROXIMATELY TWO MONTHS POST-IMPLANTATION. IT WAS NOTED, THE PROXIMAL BODY OR STEM SEEMS TO HAVE ROTATED, PLAN WAS TO REVISE PROXIMAL BODY HOWEVER THE PROXIMAL BODY COULD NOT BE MOVED, AND THE SCREW SEEMED CROSS THREADED, SO SURGEON REMOVED ENTIRE COMPONENT. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; TO DATE NO ADDITIONAL INFORMATION OR PRODUCT HAS BEEN RECEIVED.
Patient problems: Aseptic loosening
MAUDE report 25315563 ↗InjuryMay 21, 2026Detachment of Device or Device Component
IT WAS REPORTED THAT ONE DAY POST HIP REVISION, THE PATIENT UNDERWENT A HIP REVISION DUE TO A DISLOCATION. THE PROXIMAL BODY AND DISTAL STEM WERE FOUND TO BE LOOSE AND NOT MATED PROPERLY. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: Joint Dislocation
MAUDE report 25244611 ↗InjuryMay 21, 2026Detachment of Device or Device Component
IT WAS REPORTED THAT ONE DAY POST HIP REVISION, THE PATIENT UNDERWENT A HIP REVISION DUE TO A DISLOCATION. THE PROXIMAL BODY AND DISTAL STEM WERE FOUND TO BE LOOSE AND NOT MATED PROPERLY. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: Joint Dislocation
MAUDE report 25244608 ↗InjuryMay 20, 2026Loosening of Implant Not Related to Bone-Ingrowth
IT WAS REPORTED THAT THE PATIENT UNDERWENT A HIP REVISION APPROXIMATELY THREE YEARS POST-IMPLANTATION DUE TO PAIN AND RADIOLUCENCY OF COMPONENT. IT WAS CONFIRMED THAT NO FURTHER INFORMATION COULD BE PROVIDED.
Patient problems: Pain; Radiolucent Lines
MAUDE report 25230147 ↗InjuryMay 20, 2026Loosening of Implant Not Related to Bone-Ingrowth
IT WAS REPORTED THAT THE PATIENT UNDERWENT A HIP REVISION APPROXIMATELY THREE YEARS POST-IMPLANTATION DUE TO PAIN AND RADIOLUCENCY OF COMPONENT. IT WAS CONFIRMED THAT NO FURTHER INFORMATION COULD BE PROVIDED.
Patient problems: Pain; Radiolucent Lines
MAUDE report 25230117 ↗InjuryMay 15, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT APPROXIMATELY TWO MONTHS POST-HIP PROCEDURE, THE PATIENT PRESENTED WITH SEPTIC SHOCK DUE TO MRSA INFECTION IN THE HIP. THEY HAD FEVERS, DIFFICULTY WALKING, SWELLING, ABSCESS, AND POSITIVE CULTURES FOR MRSA AND SEPTIC SHOCK. THE HEAD WAS EXCHANGED IN AN I&D PROCEDURE BEFORE THE STAGE ONE REVISION ONE MONTH LATER. OP RECORDS NOTE PURULENT FLUID, LARGE FASCIAL DEHISCENCE. ALL COMPONENTS WERE REPLACED WITH A CEMENT SPACER DURING STAGE ONE WITHOUT COMPLICATIONS. THE STAGE TWO REVISION TOOK PLACE FOUR MONTHS LATER. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: Abscess; Ambulation or Postural Difficulties; Bacterial Infection; Medical device site infection; Purulent Discharge; Scar Tissue; Sepsis; Septic Shock; Swelling/ Edema; Wound Dehiscence
MAUDE report 25184346 ↗InjuryMay 15, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT APPROXIMATELY TWO MONTHS POST-HIP PROCEDURE, THE PATIENT PRESENTED WITH SEPTIC SHOCK DUE TO MRSA INFECTION IN THE HIP. THEY HAD FEVERS, DIFFICULTY WALKING, SWELLING, ABSCESS, AND POSITIVE CULTURES FOR MRSA AND SEPTIC SHOCK. THE HEAD WAS EXCHANGED IN AN I&D PROCEDURE BEFORE THE STAGE ONE REVISION ONE MONTH LATER. OP RECORDS NOTE PURULENT FLUID, LARGE FASCIAL DEHISCENCE. ALL COMPONENTS WERE REPLACED WITH A CEMENT SPACER DURING STAGE ONE WITHOUT COMPLICATIONS. THE STAGE TWO REVISION TOOK PLACE FOUR MONTHS LATER. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: Abscess; Ambulation or Postural Difficulties; Bacterial Infection; Medical device site infection; Purulent Discharge; Scar Tissue; Sepsis; Septic Shock; Swelling/ Edema; Wound Dehiscence
MAUDE report 25184332 ↗
Other Biomet Orthopedics, LLC products
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- Comprehensive Reverse Shoulder57 models · 895 reports · 3 recalls
- Vanguard Knee System147 models · 306 reports · 13 recalls
- STAGEONE17 models · 0 reports · 18 recalls
- StageOne Select15 models · 2 reports · 15 recalls
- Comprehensive Shoulder System68 models · 191 reports · 11 recalls
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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