INSTRUMENTRecalls & reported problems across all models
Howmedica Osteonics Corp. · 131 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
6 open recalls name at least one INSTRUMENT model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 290
- Deaths reported
- 0
- Injuries reported
- 52
- Recalls
- 7
We found 131 models of INSTRUMENT by Howmedica Osteonics Corp. in the FDA's device registry (GUDID). Together they are named in 290 adverse event reports in the FDA's MAUDE database, received between Jan 5, 2017 and Apr 21, 2026 — classified as 52 injuries, 238 malfunctions.
The most frequently reported specific device problem is “Fracture” (140 reports).
7 FDA recall records name at least one of these models by its device identifier, 6 still open.
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
INSTRUMENT 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.
- May 23, 2024Open, Classified
The design of the HRIS Storage & Sterilization Case and Tray P/N 6210-9-900 and the Gray Revision Instrument System Accessory Tray/Case P/N 6210-9-910 may lead to misuse of the Gray Revision Instruments including re-use and re-sterilization of the single-use, sterile-packaged instruments.
Z-2153-2024 · Root cause: Device Design · Recall details · FDA record ↗
- May 23, 2024Open, Classified
The design of the HRIS Storage & Sterilization Case and Tray P/N 6210-9-900 and the Gray Revision Instrument System Accessory Tray/Case P/N 6210-9-910 may lead to misuse of the Gray Revision Instruments including re-use and re-sterilization of the single-use, sterile-packaged instruments.
Z-2152-2024 · Root cause: Device Design · Recall details · FDA record ↗
- Dec 22, 2023Open, Classified
Failed to meet the acceptance criteria for the seal integrity and/or package integrity testing for the Sterile Barrier Outer Pouch and the Protective Barrier Inner Pouch, compromising product sterility
Z-1000-2024 · Root cause: Package design/selection · Recall details · FDA record ↗
- Dec 22, 2023Open, Classified
Failed to meet the acceptance criteria for the seal integrity and/or package integrity testing for the Sterile Barrier Outer Pouch and the Protective Barrier Inner Pouch, compromising product sterility
Z-0999-2024 · Root cause: Package design/selection · Recall details · FDA record ↗
- May 3, 2023Open, Classified
The Exeter V40 Trial Head, catalog number 6364-8-026 (size 26mm, -3) may appear green, when it is meant to be a blue color. Green signifies a size 26mm, +3 Trial Head.
Z-1921-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
- Nov 24, 2021Open, Classified
Triathlon Pro Tibial Preparation Tray may have been kitted with the Triathlon Cemented #1-3 Keel Punch (P/N: 6541-2-013) instead of the Triathlon Pro #0-3 Cemented Keel Punch (P/N: 6541-2-013Y) instrument can lead to delay in surgery or if used could lead to unintended bone preparation
Z-0459-2022 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
- Mar 5, 2021Terminated
The posterior condyle of the Specialty Triathlon TS Trial Cutting Guide(s), sizes 1 through 8, (Left and Right) has the potential to fracture at the augment cut slot. This can occur in the Trial Cutting Guide packaging during transport or during impaction of the instrument in surgery.
Z-1379-2021 · Root cause: Under Investigation by firm · names 16 of these models · Recall details · FDA record ↗
Most reported INSTRUMENT problems
Device problems
- Fracture140
- Break56
- Insufficient Device Problem Information18
- Device Difficult to Setup or Prepare14
- Difficult to Remove12
- Material Fragmentation12
- Delamination10
- Crack9
Patient problems
- No Clinical Signs, Symptoms or Conditions117
- No Consequences Or Impact To Patient72
- No Known Impact Or Consequence To Patient53
- No Patient Involvement22
- Insufficient Information21
- Injury17
- Bone Fracture(s)14
- Foreign Body In Patient10
INSTRUMENT models
131 models, 100 per page, most reported first. Each model has its own page with its reports, recalls and device details.
- INSTRUMENT I-K3834CG6RPROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 recall1 report
- INSTRUMENT 6210-5-100ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1 recall0 reports
- INSTRUMENT 6210-5-200ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1 recall0 reports
- INSTRUMENT 6364-8-026ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1 recall0 reports
- INSTRUMENT 6210-9-910ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1 recall0 reports
- INSTRUMENT 6210-9-900ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1 recall0 reports
- INSTRUMENT I-K3834CG1LPROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER1 recall0 reports
- INSTRUMENT I-K3834CG1RPROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 recall0 reports
- INSTRUMENT I-K3834CG8RPROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER1 recall0 reports
- INSTRUMENT I-K3834CG8LPROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER1 recall0 reports
- INSTRUMENT I-K3834CG7LPROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER1 recall0 reports
- INSTRUMENT I-K3834CG7RPROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 recall0 reports
- INSTRUMENT I-K3834CG6LPROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 recall0 reports
- INSTRUMENT I-K3834CG5RPROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 recall0 reports
- INSTRUMENT I-K3834CG5LPROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER1 recall0 reports
- INSTRUMENT I-K3834CG4RPROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER1 recall0 reports
- INSTRUMENT I-K3834CG4LPROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER1 recall0 reports
- INSTRUMENT I-K3834CG3RPROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 recall0 reports
- INSTRUMENT I-K3834CG3LPROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 recall0 reports
- INSTRUMENT I-K3834CG2RPROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 recall0 reports
- INSTRUMENT I-K3834CG2LPROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 recall0 reports
- INSTRUMENT 6541-9-109TRAY, SURGICAL, INSTRUMENT1 recall0 reports
- INSTRUMENT 2107-2200PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED36 reports
- INSTRUMENT 2101-0200Prosthesis, hip, semi-constrained, uncemented, metal/polymer, porous27 reports
- INSTRUMENT 6260-4-090Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented24 reports
- INSTRUMENT 1440-2011Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented14 reports
- INSTRUMENT 6278-9-070ORTHOPEDIC MANUAL SURGICAL INSTRUMENT13 reports
- INSTRUMENT 6541-4-518BIT, DRILL10 reports
- INSTRUMENT 2102-0410Screw, fixation, bone8 reports
- INSTRUMENT 1020-5204Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous cemented, osteophilic finish6 reports
- INSTRUMENT 1020-5206Prosthesis, hip, semi-constrained, metal/polymer, cemented6 reports
- INSTRUMENT 1440-2010Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous cemented, osteophilic finish5 reports
- INSTRUMENT 6541-4-709CHISEL, SURGICAL, MANUAL4 reports
- INSTRUMENT 2107-3325Prosthesis, hip, hemi-, femoral, metal4 reports
- INSTRUMENT 7650-1956ORTHOPEDIC MANUAL SURGICAL INSTRUMENT4 reports
- INSTRUMENT I-K4233KT0RGuide, surgical, instrument4 reports
- INSTRUMENT I-K4233KT0LGuide, surgical, instrument4 reports
- INSTRUMENT 6496-9-056ORTHOPEDIC MANUAL SURGICAL INSTRUMENT3 reports
- INSTRUMENT 6541-4-575ORTHOPEDIC MANUAL SURGICAL INSTRUMENT3 reports
- INSTRUMENT 2199-2022Prosthesis, hip, semi-constrained, uncemented, metal/polymer, porous3 reports
- INSTRUMENT 1020-5205Prosthesis, hip, hemi-, femoral, metal3 reports
- INSTRUMENT 1020-1860Prosthesis, hip, constrained, cemented or uncemented, metal/polymer3 reports
- INSTRUMENT 5530-T-609YPROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER3 reports
- INSTRUMENT I-K4112OT00ORTHOPEDIC MANUAL SURGICAL INSTRUMENT3 reports
- INSTRUMENT 6210-0-720ORTHOPEDIC MANUAL SURGICAL INSTRUMENT2 reports
- INSTRUMENT 6541-4-809DRIVER, PROSTHESIS2 reports
- INSTRUMENT 6496-9-054ORTHOPEDIC MANUAL SURGICAL INSTRUMENT2 reports
- INSTRUMENT 2107-1015Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented2 reports
- INSTRUMENT 6266-5-308ORTHOPEDIC MANUAL SURGICAL INSTRUMENT2 reports
- INSTRUMENT 6541-2-046PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER2 reports
- INSTRUMENT 6541-4-515ORTHOPEDIC MANUAL SURGICAL INSTRUMENT2 reports
- INSTRUMENT 1020-5203Prosthesis, hip, semi-constrained, metal/polymer, uncemented2 reports
- INSTRUMENT 6633-9-986ORTHOPEDIC MANUAL SURGICAL INSTRUMENT2 reports
- INSTRUMENT I-K27280809ORTHOPEDIC MANUAL SURGICAL INSTRUMENT2 reports
- INSTRUMENT I-K2218FP00ORTHOPEDIC MANUAL SURGICAL INSTRUMENT2 reports
- INSTRUMENT I-H2022AG00Prosthesis, hip, semi-constrained, metal/polymer, cemented2 reports
- INSTRUMENT 6541-4-003AORTHOPEDIC MANUAL SURGICAL INSTRUMENT1 report
- INSTRUMENT 0581-3-371Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented1 report
- INSTRUMENT 6778-7-060ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1 report
- INSTRUMENT 6210-0-740ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1 report
- INSTRUMENT 5550-T-360PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER1 report
- INSTRUMENT 6541-2-610Guide, surgical, instrument1 report
- INSTRUMENT 6541-3-339PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER1 report
- INSTRUMENT 0939-0-002MProsthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented1 report
- INSTRUMENT 6496-9-055ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1 report
- INSTRUMENT 6496-9-068ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1 report
- INSTRUMENT 5511-T-202PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 report
- INSTRUMENT 0580-355-0Prosthesis, hip, semi-constrained, metal/polymer, cemented1 report
- INSTRUMENT 0580-3744-0Prosthesis, hip, semi-constrained, metal/polymer, cemented1 report
- INSTRUMENT 1020-1200Prosthesis, hip, semi-constrained, metal/polymer, cemented1 report
- INSTRUMENT 0580-3744-1Screw, fixation, bone1 report
- INSTRUMENT 1020-1100Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented1 report
- INSTRUMENT 1020-1500Prosthesis, hip, constrained, cemented or uncemented, metal/polymer1 report
- INSTRUMENT 1020-2730PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED1 report
- INSTRUMENT 1020-2740Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented1 report
- INSTRUMENT 1020-3235Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate1 report
- INSTRUMENT 1020-2735Prosthesis, hip, semi-constrained, metal/polymer, uncemented1 report
- INSTRUMENT 2107-1014Prosthesis, hip, hemi-, femoral, metal1 report
- INSTRUMENT 2107-4025Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented1 report
- INSTRUMENT 2107-3340Prosthesis, hip, semi-constrained, metal/polymer, uncemented1 report
- INSTRUMENT 6266-5-311ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1 report
- INSTRUMENT 6278-1-519ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1 report
- INSTRUMENT 6633-7-738Guide, surgical, instrument1 report
- INSTRUMENT 6633-7-736Guide, surgical, instrument1 report
- INSTRUMENT 8000-0000ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1 report
- INSTRUMENT 1150-2600ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1 report
- INSTRUMENT 6541-1-721Guide, surgical, instrument1 report
- INSTRUMENT 6541-4-813IMPACTOR1 report
- INSTRUMENT 6541-4-810ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1 report
- INSTRUMENT 6541-1-605PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 report
- INSTRUMENT 6541-2-013PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 report
- INSTRUMENT 6541-4-807EXTRACTOR1 report
- INSTRUMENT 6541-4-800DRIVER, PROSTHESIS1 report
- INSTRUMENT 2000-2000ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1 report
- INSTRUMENT 6541-5-705PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER1 report
- INSTRUMENT 6541-5-713PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER1 report
- INSTRUMENT 6541-6-611ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1 report
- INSTRUMENT 6541-5-712PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER1 report
- INSTRUMENT 6541-7-815ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1 report
- INSTRUMENT 6543-7-602Guide, surgical, instrument1 report
Recent INSTRUMENT adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryApr 21, 2026Fracture; Material Fragmentation
THE FOLLOWING INFORMATION WAS PROVIDED: "DURING THE GMRS DISTAL FEMUR PROCEDURE, AN EXETER INTRAMEDULLARY PLUG WAS BEING INSERTED INTO FEMUR. THE REQUIRED DEPTH HAD NOT YET BEEN REACHED WHEN THE INSERTER SUDDENLY GAVE WAY. PLUG INTRODUCER WAS WITHDRAWN, AND IT WAS NOTED THAT THE TIP HAD BROKEN OFF. THE DEPTH WAS INSUFFICIENT. THE TIP PLUG INTRODUCER HAD PENETRATED THROUGH THE FEMUR, A FLUOROSCOPIC IMAGE WAS TAKEN. DUE TO THIS PERFORATION, THE SURGEON DECIDED THAT AN EXTENSION PIECE WAS REQUIRED TO ALLOW THE STEM TO BYPASS THE DAMAGED AREA. THE 17 MM STEM THAT HAD BEEN PREPARED WAS TOO LARGE AFTER RE-CUTTING, AND A SMALLER ONE HAD TO BE SELECTED. A STRYKER REPRESENTATIVE WAS PRESENT IN THE OPERATING ROOM PROVIDING TECHNICAL SUPPORT." THE FEMUR HAD TO BE CUT 60 MM MORE THAN ORIGINALLY WAS PLANNED BECAUSE THE SURGEON WANTED THE STEM TO EXTEND OVER THE PENETRATION POINT.
Patient problems: Bone Fracture(s)
MAUDE report 24936439 ↗InjuryApr 14, 2026Fracture
THE FOLLOWING INFORMATION WAS PROVIDED: ON MONDAY, (B)(6) 2026 DURING A TOTAL HIP REPLACEMENT SURGERY, A CURETTE FROM THE ACCOLADE STEM INSTRUMENT BROKE DURING THE PROCEDURE. THIS CURETTE IS USED TO PREPARE THE INTRAMEDULLARY CANAL PRIOR TO IMPLANTING THE ACCOLADE STEM AND IS ALSO LEFT IN PLACE AS A TRIAL STEM. DURING THE PROCEDURE, THE METAL SEGMENT WHERE THE EXTRACTOR IS INSERTED BROKE, PREVENTING ITS NORMAL REMOVAL FROM THE PATIENT. THE SURGEON HAD TO PERFORM A FEMORAL OSTEOTOMY TO REMOVE THE STEM, FOLLOWED BY A WIRE FIXATION, WHICH RESULTED IN A LONGER SURGICAL TIME AND AN ADDITIONAL, UNPLANNED PROCEDURE FOR THE PATIENT. THE PATIENT INDICATED THAT HE WILL BE TAKING LEGAL ACTION TO THE CLINIC AND WITH STRYKER. PROCEDURE IDENTIFICATION: LEFT HIP REPLACEMENT WITH TRIDENT1 ACETABULAR CUP AND ACCOLADE STEM.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 24870190 ↗MalfunctionFeb 2, 2026Fracture
THE FOLLOWING INFORMATION WAS PROVIDED: SURGEONS WERE REMOVING A REMOVABLE HIP PROSTHESIS (RESTORATION MODULAR), WHICH WAS STUCK AND A PART OF THE BODY/STEM SEPARATOR INSTRUMENT WAS BROKEN WHEN THEY ATTEMPTED TO SEPARATE THE PROXIMAL FROM THE DISTAL PART OF THE PROSTHESIS. THE INSTRUMENT PART BROKE AT THE SAME LOCATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24240518 ↗MalfunctionJan 16, 2026Fracture
THE FOLLOWING INFORMATION WAS PROVIDED: IT WAS REPORTED THAT THE PATIENT'S LEFT HIP WAS REVISED DUE TO INSTABILITY. A CERAMIC HEAD AND ADM/ MDM POLY INSERT WERE REVISED TO A 28+2 METAL HEAD WITH ANOTHER ADM/ MDM POLY INSERT. INTRA-OPERATIVELY, THE FOLLOWING OCCURRED: WEAR OF THE TRUNNION WAS NOTED. SURGEON ATTEMPTED TO REMOVE THE 22 +10 PROXIMAL CONE BODY, AND WHILE USING A MALLET ON THE IMPLANT EXTRACTOR, BROKE IT. NOTHING REMAINED IN THE PATIENT. THE BOLT FROM THE OLD CONE BODY WAS REMOVED, AND A BOLT FROM A NEW CONE BODY WAS IMPLANTED. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24093557 ↗MalfunctionJan 13, 2026Fracture; Material Fragmentation
THE FOLLOWING INFORMATION WAS PROVIDED: ¿BROKEN FRAGMENT ON TRIAL INLAY 6 × 9 MM TRIATHLON.¿
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24052158 ↗MalfunctionDec 29, 2025Fracture; Fracture
THE CS INSERT TRAIL 5X9MM POLY WAS CHIPPED ON THE CORNER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23919272 ↗MalfunctionDec 19, 2025Fracture; Material Fragmentation; Fracture; Material Fragmentation
THE TRIAL WAS PARTIALLY DAMAGED, AND FRAGMENTS WERE FOUND AND REMOVED FROM THE KNEE JOINT SURFACE. WE UNDERSTAND THERE WAS NO PARTICULAR IMPACT ON THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23847409 ↗MalfunctionDec 18, 2025Fracture; Fracture
THE FOLLOWING INFORMATION WAS PROVIDED: DAMAGE OF TRIAL INSERT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23836456 ↗MalfunctionDec 18, 2025Fracture; Fracture
SURGEONS WERE REMOVING A REMOVABLE HIP PROSTHESIS (RESTORATION MODULAR), WHICH WAS STUCK AND A PART OF THE BODY/STEM SEPARATOR INSTRUMENT WAS BROKEN WHEN THEY ATTEMPTED TO SEPARATE THE PROXIMAL FROM THE DISTAL PART OF THE PROSTHESIS. THE INSTRUMENT PART BROKE AT THE SAME LOCATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23836341 ↗MalfunctionDec 17, 2025Fracture; Material Fragmentation; Fracture; Material Fragmentation
NO NEW INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23827357 ↗MalfunctionDec 12, 2025Fracture; Fracture
NO NEW INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23794681 ↗MalfunctionDec 12, 2025Fracture; Fracture
THE FOLLOWING INFORMATION WAS PROVIDED: A MALLET WAS USED TO IMPACT THE TRIAL INTO THE JOINT AND IT WAS DAMAGED IN THE PROCESS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23789123 ↗MalfunctionDec 12, 2025Fracture; Fracture
THE FOLLOWING INFORMATION WAS PROVIDED: PROBE INLAY CR 3 X 9MM: CHIPPED PLASTIC.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23788972 ↗MalfunctionDec 9, 2025Fracture; Fracture
MalfunctionDec 4, 2025Fracture; Material Fragmentation; Fracture; Material Fragmentation
POSTERIOR PART OF THE TRIAL INLAY BROKE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23720336 ↗
Other Howmedica Osteonics Corp. products
- Triathlon608 models · 3,524 reports · 15 recalls
- Scorpio107 models · 113 reports · 28 recalls
- Trident160 models · 1,280 reports · 2 recalls
- Accolade57 models · 1,228 reports
- Duracon58 models · 65 reports · 16 recalls
- LFIT23 models · 852 reports
- TRIDENT II42 models · 188 reports · 12 recalls
- EXETER36 models · 344 reports · 3 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.
How reports and recalls are matched · Editorial policy · Report an error on this page