RestorationRecalls & reported problems across all models
Howmedica Osteonics Corp. · 86 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 219
- Deaths reported
- 0
- Injuries reported
- 174
- Recalls
- 0
We found 86 models of Restoration by Howmedica Osteonics Corp. in the FDA's device registry (GUDID). Together they are named in 219 adverse event reports in the FDA's MAUDE database, received between Jan 14, 2015 and Apr 28, 2026 — classified as 174 injuries, 45 malfunctions.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (48 reports).
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
Most reported Restoration problems
Device problems
- Insufficient Device Problem Information48
- Adverse Event Without Identified Device or Use Problem32
- Fracture31
- Packaging Problem30
- Device Dislodged or Dislocated23
- Component Misassembled22
- Degraded17
- Loss of Osseointegration12
Patient problems
- Injury94
- No Consequences Or Impact To Patient34
- Inadequate Osseointegration33
- Pain28
- Insufficient Information19
- Ambulation or Postural Difficulties18
- Joint Dislocation18
- No Known Impact Or Consequence To Patient18
Restoration models
86 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Restoration 6276-1-019Prosthesis, hip, constrained, cemented or uncemented, metal/polymer10 reports
- Restoration 6276-7-015Prosthesis, hip, hemi-, femoral, metal9 reports
- Restoration 6276-1-021Prosthesis, hip, hemi-, femoral, metal7 reports
- Restoration 6276-1-221PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED7 reports
- Restoration 6276-7-016Prosthesis, hip, semi-constrained, metal/polymer, uncemented7 reports
- Restoration 2080-0020Prosthesis, hip, semi-constrained, uncemented, metal / polymer, non-porous, calcium phosphate7 reports
- Restoration 6276-1-025Prosthesis, hip, semi-constrained, metal/polymer, cemented6 reports
- Restoration 6276-1-123Prosthesis, hip, semi-constrained, uncemented, metal/polymer, porous6 reports
- Restoration 6276-7-014Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented6 reports
- Restoration 2080-0030Prosthesis, hip, semi-constrained, uncemented, metal / polymer, non-porous, calcium phosphate6 reports
- Restoration 6276-1-023Prosthesis, hip, semi-constrained, metal/polymer, uncemented5 reports
- Restoration 6276-1-119Prosthesis, hip, semi-constrained, metal/polymer, uncemented5 reports
- Restoration 6276-1-125Prosthesis, hip, semi-constrained, metal/polymer, uncemented5 reports
- Restoration 504-02-68F-RPROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED5 reports
- Restoration 6276-7-017Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented4 reports
- Restoration 6276-1-321Prosthesis, hip, semi-constrained, metal/polymer, uncemented4 reports
- Restoration 504-02-54C-RPROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED4 reports
- Restoration 504-02-62E-RPROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED4 reports
- Restoration 504-02-62E-LPROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED4 reports
- Restoration 504-02-66F-LPROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED4 reports
- Restoration 2080-0025Prosthesis, hip, semi-constrained, uncemented, metal / polymer, non-porous, calcium phosphate4 reports
- Restoration 6276-1-121Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate3 reports
- Restoration 6276-1-127Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous cemented, osteophilic finish3 reports
- Restoration 6276-7-116Prosthesis, hip, hemi-, femoral, metal3 reports
- Restoration 504-02-64E-RPROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED3 reports
- Restoration 504-02-68F-LPROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED3 reports
- Restoration 2080-0015Prosthesis, hip, semi-constrained, uncemented, metal / polymer, non-porous, calcium phosphate3 reports
- Restoration 2080-0040Prosthesis, hip, semi-constrained, uncemented, metal / polymer, non-porous, calcium phosphate3 reports
- Restoration 2080-0045Prosthesis, hip, semi-constrained, uncemented, metal / polymer, non-porous, calcium phosphate3 reports
- Restoration 1235-2-501Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous cemented, osteophilic finish2 reports
- Restoration 1235-2-502Prosthesis, hip, hemi-, femoral, metal2 reports
- Restoration 1235-2-542Prosthesis, hip, semi-constrained, uncemented, metal/polymer, porous2 reports
- Restoration 1235-2-561PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED2 reports
- Restoration 1235-2-601Prosthesis, hip, hemi-, femoral, metal2 reports
- Restoration 6276-1-225Prosthesis, hip, semi-constrained, metal/polymer, cemented2 reports
- Restoration 6276-1-227PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED2 reports
- Restoration 6276-3-004Prosthesis, hip, semi-constrained, uncemented, metal/polymer, porous2 reports
- Restoration 6276-4-123Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate2 reports
- Restoration 6276-7-020Prosthesis, hip, semi-constrained, uncemented, metal/polymer, porous2 reports
- Restoration 6276-7-021Prosthesis, hip, semi-constrained, metal/polymer, cemented2 reports
- Restoration 6276-7-216Prosthesis, hip, semi-constrained, uncemented, metal/polymer, porous2 reports
- Restoration 504-02-54C-LPROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED2 reports
- Restoration 504-02-56D-LPROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED2 reports
- Restoration 504-02-58D-LPROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED2 reports
- Restoration 504-02-58D-RPROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED2 reports
- Restoration 504-02-64E-LPROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED2 reports
- Restoration 2082-0052LProsthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented2 reports
- Restoration 2080-0035Prosthesis, hip, semi-constrained, uncemented, metal / polymer, non-porous, calcium phosphate2 reports
- Restoration 1235-2-481Prosthesis, hip, semi-constrained, uncemented, metal/polymer, porous1 report
- Restoration 1235-2-521Prosthesis, hip, semi-constrained, metal/polymer, uncemented1 report
- Restoration 1235-2-522Prosthesis, hip, hemi-, femoral, metal1 report
- Restoration 1235-2-562Prosthesis, hip, constrained, cemented or uncemented, metal/polymer1 report
- Restoration 1235-2-581Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous cemented, osteophilic finish1 report
- Restoration 1235-2-642PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED1 report
- Restoration 1235-2-852Prosthesis, hip, semi-constrained, metal/polymer, cemented1 report
- Restoration 6276-1-027Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate1 report
- Restoration 6276-5-011Prosthesis, hip, hemi-, femoral, metal1 report
- Restoration 6276-5-014Prosthesis, hip, semi-constrained, metal/polymer, cemented1 report
- Restoration 6276-7-018Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented1 report
- Restoration 6276-1-319Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented1 report
- Restoration 6276-2-125Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate1 report
- Restoration 6276-4-319Prosthesis, hip, hemi-, femoral, metal1 report
- Restoration 6260-6-313Prosthesis, hip, constrained, cemented or uncemented, metal/polymer1 report
- Restoration 6276-1-031Prosthesis, hip, constrained, cemented or uncemented, metal/polymer1 report
- Restoration 6276-1-231Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate1 report
- Restoration 6276-1-323Prosthesis, hip, semi-constrained, metal/polymer, uncemented1 report
- Restoration 6276-1-327Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented1 report
- Restoration 6276-7-114Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented1 report
- Restoration 6276-7-115Prosthesis, hip, hemi-, femoral, metal1 report
- Restoration 6276-7-117Prosthesis, hip, semi-constrained, metal/polymer, uncemented1 report
- Restoration 6276-7-120Prosthesis, hip, hemi-, femoral, metal1 report
- Restoration 6276-7-121Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate1 report
- Restoration 6276-7-122Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented1 report
- Restoration 6276-7-214Prosthesis, hip, semi-constrained, uncemented, metal/polymer, porous1 report
- Restoration 6276-7-217Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate1 report
- Restoration 6276-7-218Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous cemented, osteophilic finish1 report
- Restoration 6276-7-317Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate1 report
- Restoration 504-02-56D-RPROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED1 report
- Restoration 504-02-60D-RPROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED1 report
- Restoration 504-02-60D-LPROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED1 report
- Restoration 2082-0056RProsthesis, hip, semi-constrained, metal/polymer, cemented1 report
- Restoration 2082-0068RProsthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented1 report
- Restoration 6522-0511Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate1 report
- Restoration S-2651-0812Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented1 report
- Restoration S-2652-1117Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate1 report
- Restoration S-2652-1218Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented1 report
Recent Restoration adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryApr 28, 2026Device Dislodged or Dislocated
THE FOLLOWING INFORMATION WAS PROVIDED: AS REPORTED BY HCP: I JUST RECEIVED WORD THAT OUR COMPASSIONATE USE PATIENT WAS SENT TO THE EMERGENCY DEPARTMENT FROM THE ORTHO CLINIC. PATIENT HAD HER 8 WEEK FOLLOW UP IN CLINIC TODAY WITH COMPLAINTS OF NEW ONSET RIGHT HIP PAIN AND CLICKING FOR THE LAST 2 WEEKS. ON X-RAY, THE HIP WAS FOUND TO BE DISLOCATED. SHE HAS BEEN ADMITTED TO THE HOSPITAL AND WILL HAVE A REVISION TOMORROW. WE'LL KNOW MORE TOMORROW. PER PSS TEAM: A PATIENT SPECIFIC FLANGED ACETABULAR CUP (P/N: C-MM100731-00) WAS IMPLANTED. ADDITIONAL INFORMATION FROM SALES REP: THE ENTIRE ((B)(6) 2026) REVISION WAS STRYKER PROJECTS WITH REST MOD IN THE FEMUR AND MDM CONSTRUCT IN THE CUP (NOTE: THE (B)(6) 2026 SURGERY TO IMPLANT STRYKER IMPLANTS WAS A REVISION OF NON-STRYKER IMPLANTS). THE REASON FOR THE DISLOCATION WAS A BRACE WAS REMOVED FROM THE PATIENT DURING PT (BRACE WAS REMOVED BY PHYSICAL THERAPIST AGAINST SURGEON ADVICE AFTER HAVING BEEN ASKED 3 TIMES TO REMOVE THE BRACE) AND HER ENTIRE GREATER TROCHANTER BROKE OFF DUE OVER MOVEMENT OF THE OPERATIVE LEG. IT WAS DISCOVERED YESTERDAY, IN SURGERY, THAT HER ABDUCTORS WERE NO LONGER ATTACHED TO KEEP THE HIP IN PLACE. THE MDM CONSTRUC
Patient problems: Joint Dislocation
MAUDE report 25017086 ↗InjuryNov 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryAug 18, 2025Fracture; Fracture
NO NEW INFORMATION.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 22834516 ↗InjuryJun 6, 2025Fracture; Fracture
NO NEW INFORMATION.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 22158864 ↗InjuryMay 19, 2025Fracture; Fracture
REVISION HIP OF AN ACCOLADE II (IMPLANTED IN 2020) DUE TO SUBSIDENCE REVISED TO RESTORATION MODULAR STEM. DURING SURGEON TIGHTENING OF PROXIMAL CONICAL BODY WITH 5MM HEX THE SCREW SNAPPED AT ~5MM DISTAL END OF SCREW THREAD. SURGEON RETRIEVED SNAPPED END OF SCREW FROM PATIENT. PROXIMAL CONE BODY RE-IMPLANTED AND NEW PROXIMAL CONE BODY SCREW TIGHTENED WITH HEX SCREW AND TORQUE WRENCH WITHOUT ISSUE.
Patient problems: Insufficient Information
MAUDE report 22042705 ↗InjuryApr 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
SURGEON ADVISED IN THE SCRUB BAY THAT THE 'REVISION FROM THURSDAY WAS INFECTED'. WE HAD TAKEN SWABS DURING HIS REVISION SURGERY AND THEY HAD GROWN CULTURES. DOCTOR TELLS ME WE ARE NO LONGER DOING THIS PATIENTS SUBSEQUENT REVISION HIP REPLACEMENT. THE PLAN IS NOW TO MANAGE WITH ANTIBIOTICS AND NOT REVISE.
Patient problems: Unspecified Infection
MAUDE report 21890169 ↗InjuryMar 31, 2025Fracture; Fracture
PATIENT REPORTED THAT THEY HAD A SECOND REVISION WITH STRYKER IMPLANTS ON (B)(6) 2024 FOR PAIN. THEY FURTHER STATED THAT IT WAS NOTED DURING THE PROCEDURE THAT THE TIP OF THE PROSTHETIC IN THE FEMUR HAD BROKEN OFF AND COME LOOSE. THE BROKEN PIECE AT THE VERY DISTAL END OF THE FEMORAL COMPONENT WAS LEFT IN THE PATIENT, RIGHT HIP.
Patient problems: Pain
MAUDE report 21730307 ↗InjuryMar 30, 2025Degraded; Insufficient Device Problem Information; Degraded; Insufficient Device Problem Information
"TODAY AT ORTHOPAEDIC CENTRE, WE REVISED A RESTORATION MODULAR CONE BODY THAT WAS IMPLANTED APPROX 13 YEARS AGO."
Patient problems: Insufficient Information
MAUDE report 21728694 ↗InjuryMar 18, 2025Fracture; Fracture
IT WAS REPORTED BY THE PATIENT THAT ON (B)(6) 2014, HE UNDERWENT REVISION SURGERY AND WAS IMPLANTED WITH A RESTORATION MODULAR HIP SYSTEM. IN LATE ON (B)(6) 2024 HE STARTED TO EXPERIENCE EXTREME PAIN IN HIS RIGHT UPPER LEG FEMUR AREA AND HAD DIFFICULTY STANDING OR WALKING. HE WAS REVISED ON (B)(6) 2024, ALLEGEDLY DUE TO THE TIP OF THE PROSTHESIS BROKE OFF INSIDE HIS FEMUR.
Patient problems: Ambulation or Postural Difficulties; Pain
MAUDE report 21631315 ↗InjuryJan 7, 2025Fracture; Fracture
HIP REVISION SURGERY WAS REQUIRED DUE TO FRACTURE OF THE ROD IMPLANTED IN PRIMARY SURGERY. THERE WERE NO ADVERSE EVENTS IN THE REVISION SURGERY.
Patient problems: Insufficient Information
MAUDE report 21089637 ↗InjuryDec 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT'S RIGHT HIP WAS REVISED DUE TO INFECTION. ALL IMPLANTS (INCLUDING COMPETITOR ACETABULAR COMPONENTS) WERE REMOVED AND A SPACER WAS IMPLANTED. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.
Patient problems: Unspecified Infection
MAUDE report 20902211 ↗InjuryNov 26, 2024Corroded; Degraded; Corroded; Degraded
IT IS REPORTED BY COUNSEL THAT CLAIMANT UNDERWENT RIGHT THA ON (B)(6) 2014, AND WAS IMPLANTED WITH A LFIT ANATOMIC V40 FEMORAL HEAD. SUBSEQUENTLY HE DEVELOPED PAIN IN HIS GROIN, LATERAL HIP AND BUTTOCKS WITH ANY MOTION AND FELT HE WAS GETTING WEAK AND GETTING WORSE. ALLEGEDLY HIS COBALT CHROME LEVELS WERE NOT SIGNIFICANTLY ELEVATED BUT MRI WAS CONCERNING FOR POSSIBLE ADVERSE LOCAL TISSUE REACTION. HE WAS REVISED ON (B)(6) 2021 FOR ALLEGED TRUNNIONOSIS AND HEAD/TAPER CORROSION.
Patient problems: Foreign Body Reaction; Metal Related Pathology; Pain
MAUDE report 20784923 ↗InjuryJul 22, 2024Fracture; Fracture
IT WAS REPORTED THROUGH THE FILING OF A LAWSUIT THAT ALLEGEDLY ON OR ABOUT MARCH 21, 2022, IT WAS DISCOVERED THROUGH DIAGNOSTIC STUDIES THE FEMORAL STEM WAS BROKEN WHICH RESULTED IN REVISION SURGERY ON (B)(6) 2022.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19799384 ↗InjuryMay 29, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE FOLLOWING WAS REPORTED: "CEMENTED CONSTRAINED CUP DISLOCATED FOLLOWING MOVEMENT IN PATIENTS BED. CEMENTED CONSTRAINED CUP REMOVED AND REPLACED WITH A RAS SHELL, WHEN IMPACTING THE 58MM RAS SHELL THE SURGEON THEN HAD A FRACTURE IN THE MEDIAL WALL SO SHELL WAS UPSIZED TO 62MM. LEFT HIP". UPDATE: THE INNER BIPOLAR COMPONENT DISLOCATED FROM THE OUTER COMPONENT.
Patient problems: Bone Fracture(s)
MAUDE report 19420000 ↗InjuryMay 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ITS REPORTED BY THE ATTORNEY, THROUGH THE FILING OF A LAWSUIT, THAT THE PLAINTIFF UNDERWENT A LEFT TOTAL HIP ARTHROPLASTY ON (B)(6) 2017. ITS FURTHER ALLEGED THAT ELEVATED LEVELS OF CHROMIUM AND COBALT WERE REVEALED IN BLOOD WORK. PLAINTIFF HAS NOT YET BEEN REVISED.
Patient problems: Metal Related Pathology
MAUDE report 19389026 ↗
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
- INSTRUMENT131 models · 290 reports · 7 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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