EXETERRecalls & reported problems across all models
Howmedica Osteonics Corp. · 36 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names at least one EXETER model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 344
- Deaths reported
- 2
- Injuries reported
- 293
- Recalls
- 3
We found 36 models of EXETER by Howmedica Osteonics Corp. in the FDA's device registry (GUDID). Together they are named in 344 adverse event reports in the FDA's MAUDE database, received between Feb 7, 2014 and Sep 25, 2026 — classified as 2 deaths, 293 injuries, 49 malfunctions.
The most frequently reported specific device problem is “Fracture” (167 reports).
3 FDA recall records name at least one of these models by its device identifier, 1 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
EXETER 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.
- Aug 28, 2025Open, Classified
a potential product mix where the package labeled as Catalog Number 0580-1-442, lot A00976, may contain Catalog Number 0580-1-352, lot G8754849, and vice versa. Patient labels may also be impacted.
Z-2640-2025 · Root cause: Under Investigation by firm · names 2 of these models · Recall details · FDA record ↗
- Dec 30, 2021Terminated
There is a potential label mix between certain lots of Exeter V40 Cemented Hip (125mm) Stem and Exeter V40 Cemented Hip (150mm) Stem.
Z-0652-2022 · Root cause: Labeling mix-ups · Recall details · FDA record ↗
- Dec 30, 2021Terminated
There is a potential label mix between certain lots of Exeter V40 Cemented Hip (125mm) Stem and Exeter V40 Cemented Hip (150mm) Stem.
Z-0651-2022 · Root cause: Labeling mix-ups · Recall details · FDA record ↗
Most reported EXETER problems
Device problems
- Fracture167
- Adverse Event Without Identified Device or Use Problem50
- Break43
- Insufficient Device Problem Information40
- Loss of Osseointegration18
- Product Quality Problem14
- Degraded13
- Crack9
Patient problems
- Ambulation or Postural Difficulties93
- Injury91
- Insufficient Information76
- Pain53
- Bone Fracture(s)34
- Fall27
- No Consequences Or Impact To Patient22
- No Clinical Signs, Symptoms or Conditions20
EXETER models
36 models, most reported first. Each model has its own page with its reports, recalls and device details.
- EXETER 0580-1-440Prosthesis, hip, semi-constrained, metal/polymer, cemented1 recall86 reports
- EXETER 0580-1-442Prosthesis, hip, semi-constrained, metal/polymer, cemented1 recall46 reports
- EXETER 0580-1-352PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED1 recall23 reports
- EXETER 0580-1-044Prosthesis, hip, semi-constrained, metal/polymer, uncemented1 recall22 reports
- EXETER 0580-1-441Prosthesis, hip, constrained, cemented or uncemented, metal/polymer1 death31 reports
- EXETER 0580-1-351Prosthesis, hip, semi-constrained, uncemented, metal/polymer, porous29 reports
- EXETER 0580-1-501Prosthesis, hip, hemi-, femoral, metal13 reports
- EXETER 0580-1-300Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented11 reports
- EXETER 0580-1-443Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous cemented, osteophilic finish11 reports
- EXETER 0580-1-330Prosthesis, hip, semi-constrained, metal/polymer, cemented10 reports
- EXETER 0580-1-371Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented10 reports
- EXETER 0580-1-444Prosthesis, hip, constrained, cemented or uncemented, metal/polymer6 reports
- EXETER 0580-1-372PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED5 reports
- EXETER 0580-1-373Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented5 reports
- EXETER 0580-3-371Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented4 reports
- EXETER 0580-3-441Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented4 reports
- EXETER 0580-3-321Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented3 reports
- EXETER 0580-1-502PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED2 reports
- EXETER 0580-1-504Prosthesis, hip, semi-constrained, metal/polymer, uncemented2 reports
- EXETER 0580-3-422Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous cemented, osteophilic finish1 death2 reports
- EXETER 0939-0-114Prosthesis, hip, semi-constrained, metal/polymer, cemented2 reports
- EXETER 0939-0-116CEMENT OBTURATOR2 reports
- EXETER 0580-3-501Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented2 reports
- EXETER 0580-1-260PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED1 report
- EXETER 0580-1-374Prosthesis, hip, semi-constrained, uncemented, metal/polymer, porous1 report
- EXETER 0586-0-028Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented1 report
- Exeter 6309-2-846Prosthesis, hip, semi-constrained, metal/polymer, cemented1 report
- Exeter 6309-2-850Prosthesis, hip, semi-constrained, metal/polymer, cemented1 report
- Exeter 6309-3-248Prosthesis, hip, semi-constrained, metal/polymer, cemented1 report
- Exeter 6309-3-250Prosthesis, hip, semi-constrained, metal/polymer, cemented1 report
- Exeter 6309-3-260Prosthesis, hip, semi-constrained, metal/polymer, cemented1 report
- Exeter 6309-3-652Prosthesis, hip, semi-constrained, metal/polymer, cemented1 report
- Exeter 6309-4-058Prosthesis, hip, semi-constrained, metal/polymer, cemented1 report
- Exeter 6309-4-060Prosthesis, hip, semi-constrained, metal/polymer, cemented1 report
- EXETER 0580-1-562Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented1 report
- Exeter 7309-4-058Prosthesis, hip, femoral component, cemented, metal1 report
Recent EXETER adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjurySep 25, 2026Fracture
The following information was provided: It was reported that the patient's Right hip was revised due to the Exeter stem breaking approximately 63-64mm from the distal tip. No trauma/ cause for implant breakage reported. No femoral fracture was observed. The stem, head, and liner were revised. Rep confirmed there were no allegations against the revised head and liner.
Patient problems: Insufficient Information
MAUDE report 50896023 ↗InjurySep 24, 2026Loss of Osseointegration
Patient problems: Inadequate Osseointegration
MAUDE report 50892361 ↗InjurySep 16, 2026Fracture
Patient problems: Insufficient Information
MAUDE report 50794460 ↗InjurySep 16, 2026Fracture
Patient problems: Insufficient Information
MAUDE report 50794459 ↗InjuryAug 26, 2026Fracture
It was reported that the patient was having some pain and was booked for a revision because of the osteolytic lesion in femur. Surgeon was in Operating Room for surgery had dislocated the hip and pulled on the stem with his hand and out came a broken stem. Device has been in service since (b)(6) 2012. Stem was removed. ETO performed, Cement removed and a new revision Restoration Modular stem put back with Dall Miles cables.
Patient problems: Osteolysis; Pain
MAUDE report 50453263 ↗InjuryAug 6, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Bone Fracture(s)
MAUDE report 50160579 ↗InjuryJul 28, 2026Adverse Event Without Identified Device or Use Problem
The following information was provided: Stryker THA revised due to periprosthetic fracture, original stem head and liner removed, replaced with Exeter Long Stem (44 No 3 260), MDM liner (E) and 28 +4 head.
Patient problems: Ambulation or Postural Difficulties; Periprosthetic fracture
MAUDE report 50057667 ↗InjuryJun 30, 2026Adverse Event Without Identified Device or Use Problem
THE FOLLOWING INFORMATION WAS PROVIDED: A HEALTHCARE PROFESSIONAL REPORTED A PATIENT WHO UNDERWENT BILATERAL TOTAL HIP ARTHROPLASTY AT ANOTHER HOSPITAL USING THE COMPANY¿S IMPLANTS. POSTOPERATIVELY, THE PATIENT HAS BEEN EXPERIENCING VARIOUS NONSPECIFIC SYMPTOMS. THE PATIENT AND FAMILY RAISED A CONCERN REGARDING A POTENTIAL METAL ALLERGY BASED ON INFORMATION OBTAINED FROM THE INTERNET. THE REPORTING HEALTHCARE PROFESSIONAL CONSIDERS THE LIKELIHOOD OF METAL ALLERGY TO BE VERY LOW FROM A CLINICAL PERSPECTIVE. NO DEFINITIVE DIAGNOSIS OF METAL ALLERGY HAS BEEN MADE, AND NO CAUSAL RELATIONSHIP BETWEEN THE REPORTED SYMPTOMS AND THE IMPLANTS HAS BEEN ESTABLISHED.
Patient problems: High metal ion levels; Metal Related Pathology
MAUDE report 25670741 ↗InjuryJun 11, 2026Fracture
THE FOLLOWING INFORMATION WAS PROVIDED: BROKEN EXETER STEM BROKEN THROUGH MID-SHAFT OF STEM, REVISED TO LONG STEM EXETER.
Patient problems: Insufficient Information
MAUDE report 25477782 ↗InjuryMay 28, 2026Fracture
THE FOLLOWING INFORMATION WAS PROVIDED: I HAVE BEEN USING BILATERAL HIP PROSTHESES FOR 8 YEARS. ON (B)(6) 2026, I BEGAN TO FEEL SPONTANEOUS PAIN IN MY HIP (RIGHT SIDE), AND THE PAIN PROGRESSED WITH LOSS OF STRENGTH AND MOBILITY IN THE LIMB. I WAS THEN TAKEN BY AMBULANCE TO THE HOSPITAL ON (B)(6) 2026, WHERE AN X-RAY REVEALED THAT THE PROSTHESIS WAS BROKEN. THIS OCCURRED SPONTANEOUSLY, WITHOUT ANY ASSOCIATED TRAUMA. SINCE THEN, MY LIFE HAS CHANGED REPEATEDLY, AS FROM THAT DAY ON I COULD NO LONGER WALK, WORK, OR PERFORM SIMPLE DAILY ACTIVITIES. I STARTED NEEDING HELP WITH EVEN SMALL NECESSITIES LIKE DRESSING, GOING TO THE BATHROOM, LYING DOWN, ETC. IN ADDITION TO THE SIGNIFICANT EMOTIONAL IMPACT ON ME AND MY FAMILY, I WAS PHYSICALLY AND FINANCIALLY AFFECTED BY HAVING TO BEAR THE COSTS OF MEDICAL EXPENSES AND MEDICATIONS, AND BY THE HEALTH DAMAGE RELATED TO THE SURGERY, AS I HAVE SICKLE CELL ANEMIA, WHICH REQUIRED GREATER CARE AND INVOLVED RISKS. I DID EXPERIENCE COMPLICATIONS AFTER THE PROSTHESIS REPLACEMENT SURGERY, DEVELOPING A PULMONARY THROMBOEMBOLISM, WHICH FURTHER WEAKENED MY HEALTH, REQUIRING OXYGEN AND PROLONGING MY HOSPITAL STAY. I ALSO NEEDED FOUR BLOOD TRANSFUSIONS. ALL OF
Patient problems: Ambulation or Postural Difficulties
MAUDE report 25315216 ↗InjuryMay 27, 2026Fracture
THE FOLLOWING INFORMATION WAS PROVIDED: REVISION HIP REPLACEMENT FOR REMOVAL OF BROKEN EXETER STEM. DIFFICULT EXTRACTION. REPLACEMENT EXETER CEMENT IN CEMENT STEM USED.
Patient problems: Ambulation or Postural Difficulties
MAUDE report 25301273 ↗InjuryMay 19, 2026Fracture
THE FOLLOWING INFORMATION WAS PROVIDED: IT WAS REPORTED THAT THERE WAS A BROKEN EXETER STEM. THE PATIENT PRESENTED IN EMERGENCY WITH PAIN. X-RAY TAKEN. SHOWED FX OF STEM.
Patient problems: Ambulation or Postural Difficulties; Insufficient Information
MAUDE report 25213724 ↗InjuryMay 19, 2026Fracture
InjuryMay 11, 2026Adverse Event Without Identified Device or Use Problem
InjuryMay 6, 2026Fracture
THE FOLLOWING INFORMATION WAS PROVIDED: "PATIENT WITH AN EXETER STEM IMPLANTED IN LEFT HIP SINCE 10 YEARS SUDDENLY FELT PAIN WHEN WALKING INSIDE THE HOUSE AND WAS NOT ABLE TO LIFT HIS LEG. WENT TO THE ER AND WHERE THEY FIND A BROKEN STEM ON THE X-RAY AND HE WAS TAKEN TO OR THE NEXT DAY."
Patient problems: Ambulation or Postural Difficulties; Pain
MAUDE report 25091276 ↗
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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