ELITERecalls & reported problems across all models
Depuy (Ireland) · 9 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 30
- Deaths reported
- 0
- Injuries reported
- 18
- Recalls
- 0
We found 9 models of ELITE by Depuy (Ireland) in the FDA's device registry (GUDID). Together they are named in 30 adverse event reports in the FDA's MAUDE database, received between Sep 1, 2017 and May 21, 2025 — classified as 18 injuries, 12 malfunctions.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (10 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 ELITE problems
Device problems
- Device Dislodged or Dislocated10
- Adverse Event Without Identified Device or Use Problem7
- Break6
- Insufficient Device Problem Information2
- Naturally Worn2
- Appropriate Device Problem Term/Code Not Available1
- Component Missing1
- Crack1
Patient problems
- Joint Dislocation10
- No Code Available7
- No Clinical Signs, Symptoms or Conditions5
- Pain4
- Insufficient Information3
- Joint Laxity3
- No Consequences Or Impact To Patient2
- Osteolysis2
ELITE models
9 models, most reported first. Each model has its own page with its reports, recalls and device details.
- ELITE 9625-73-000Prosthesis, hip, semi-constrained, metal/polymer, cemented9 reports
- ELITE 2522-00-502DRIVER, PROSTHESIS8 reports
- ELITE 9627-34-000Prosthesis, hip, semi-constrained, metal/polymer, cemented4 reports
- ELITE 9627-35-000Prosthesis, hip, semi-constrained, metal/polymer, cemented3 reports
- ELITE 9627-30-000Prosthesis, hip, semi-constrained, metal/polymer, cemented2 reports
- ELITE 9625-67-000Prosthesis, hip, semi-constrained, metal/polymer, cemented1 report
- ELITE 9625-75-000Prosthesis, hip, semi-constrained, metal/polymer, cemented1 report
- ELITE 9627-47-000Prosthesis, hip, semi-constrained, metal/polymer, cemented1 report
- ELITE 9625-70-000Prosthesis, hip, semi-constrained, metal/polymer, cemented1 report
Recent ELITE adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionMay 21, 2025Break; Crack; Break; Crack
IT WAS REPORTED THAT AN IMPACTOR AND AN INTRODUCER ARE BROKEN.
Patient problems: Insufficient Information
MAUDE report 22062766 ↗MalfunctionApr 25, 2025Break; Break
IT WAS REPORTED THAT STEM INTRODUCER WAS BROKEN. THERE WAS NO EFFECT DURING SURGERY.
Patient problems: Insufficient Information
MAUDE report 21912905 ↗MalfunctionJan 21, 2025Break; Break
IT WAS REPORTED THAT THERE WAS A BROKEN INSTRUMENTS. THE PLASTIC CRACKED ON TWO T-HANDLES AND ONE C-STEM INSERTER WHICH HAVE TO BE DISCARDED AND REPLACED. THERE WERE NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21198840 ↗MalfunctionJun 12, 2024Break; Scratched Material; Break; Scratched Material
THE HANDLE OF THE CSTEM INTRODUCER HAS BEEN DAMAGED. A PIECE OF THE PLASTIC GRIP SCRATCHED DEEP AND IS NOT APPROPRIATE FOR STERILIZATION. NO PATIENT HARM, NO DELAYS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19525429 ↗MalfunctionApr 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT ON UNKNOWN DATE, THE PATIENT UNDERWENT THE TOTAL HIP ARTHROPLASTY WITH THE AML FOR THE HIP JOINT. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. AFTER THE SURGERY, THE AML STEM WAS BROKEN. THEREFORE, A REVISION SURGERY WILL BE PERFORMED ON (B)(6) 2022. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Insufficient Information
MAUDE report 16688479 ↗InjuryMar 2, 2023Naturally Worn; Naturally Worn
REVISED A THR OF C-STEM AND MARATHON CEMENTED CUP FROM APPROXIMATELY 20 YEARS AGO. ORIGINAL SURGEON WAS DR AND THE OPERATION WAS AT QEII JUBILEE HOSPITAL. PRIMARY REASON FOR REVISION WAS FOR INSTABILITY/LOOSENING OF THE CUP. ONCE THE PT WAS OPEN AND DISLOCATED THE SURGEON REMOVED THE HEAD FROM THE STEM. 28MM METAL HEAD +3 WITH 9/10 TAPER, THE HEAD APPEARED TO HAVE MINIMAL WEAR. DUE TO LIMITED SPACE AND ACCESS TO THE ACETABULUM THE SURGEON DECIDED TO REMOVE THE STEM. ONCE REMOVED THE STEM APPEARED TO HAVE MINIMAL WEAR WITH NIL SIGNS OF DAMAGE. SIZE 3 ? STD. THE CEMENT MANTLE FOR THE STEM REMAINED IN TACK AND WAS HAPPY TO KEEP IT FOR NEW AMT C-STEM. THE SURGEON THEN REMOVED THE MARATHON CEMENTED CUP. CUP REMOVED WITH CEMENT ATTACHED TO CUP, WITH MINIMAL OBVIOUS WEAR. UNSURE OF CUP SIZE AS NOT VISIBLE ON RIM. SURGEON THEN IMPLANTED A HYBRID ZIMMER ACETABULAR CUP AND LINER. THE SURGEON DOWNSIZED THE STEM FOR NEW CEMENT MANTLE AND ADJUSTMENT OF VERSION OF THE STEM. SIZE 2 HO C-STEM AMT. CERAMIC 36MM +1.5MM HEAD IMPLANTED. GOOD STABILITY AND IMPROVED LEG LENGTH DISCREPANCY.
Patient problems: Joint Laxity; Physical Asymmetry
MAUDE report 16467189 ↗MalfunctionDec 29, 2022Break; Break
INSTRUMENT BROKE DURING HIP SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16067560 ↗InjuryApr 1, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated
THIS (B)(4) IS RELATED TO (B)(4) WHICH REPORTS ABOUT THE DISLOCATION WHICH OCCURRED AFTER THE FIRST SURGERY. THIS PC REPORTS ABOUT THE EVENT WHICH OCCURRED IN THE REDUCTION. IT WAS REPORTED THAT ON (B)(6) 2010, THE PATIENT UNDERWENT THE PRIMARY THA SURGERY FOR OA WITH THE STEM AND THE HEAD IN QUESTION AT (B)(6) HOSPITAL. THE COMPETITORS¿ TRILOGY CUP AND THE LINER WERE COMBINED IMPLANTED. AFTER THE SURGERY, THE PATIENT HAD A DISLOCATION ON AN UNKNOWN DATE. DURING THE REDUCE, THE STEM AND THE HEAD WERE COME OFF. THE DISLODGEMENT WAS NOTICED AFTER THE REDUCTION. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2022. DOI: (B)(6) 2010; DOR: (B)(6) 2022; UNKNOWN HIP.
Patient problems: Foreign Body Reaction
MAUDE report 13976243 ↗InjuryMar 21, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated
THIS (B)(4) IS RELATED TO (B)(4) WHICH REPORTS ABOUT THE EVENT WHICH OCCURRED IN THE REDUCTION. THIS PC REPORTS ABOUT THE DISLOCATION WHICH OCCURRED AFTER THE FIRST SURGERY. IT WAS REPORTED THAT ON (B)(6) 2010, THE PATIENT UNDERWENT THE PRIMARY THA SURGERY FOR OA WITH THE STEM AND THE HEAD IN QUESTION. THE TRILOGY CUP AND THE LINER OF ANOTHER COMPANY PRODUCTS WERE COMBINED IMPLANTED. AFTER THE SURGERY, THE PATIENT HAD A DISLOCATION ON AN UNKNOWN DATE. THE REDUCTION OF DISLOCATION WAS PERFORMED ON AN UNKNOWN DATE. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Joint Dislocation
MAUDE report 13840567 ↗MalfunctionFeb 28, 2022Naturally Worn; Naturally Worn
IT WAS REPORTED AS DEFICIENT DUE TO FAIR WEAR AND TEAR. SURGERY NOT AFFECTED. OPERATION TIME NOT LENGTHENED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13619745 ↗InjuryJan 27, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION COMPLETED DUE TO INSTABILITY. DOI: UNKNOWN, DOR: (B)(6) 2022, AFFECTED SIDE: RIGHT HIP.
Patient problems: Joint Laxity
MAUDE report 13366197 ↗MalfunctionJan 11, 2022Break; Break
INSTRUMENT HANDLE BROKE INTO TWO PIECES DURING IMPACTION. NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13222761 ↗InjuryOct 13, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT ON (B)(6) 2010, THE PATIENT UNDERWENT THE THA SURGERY FOR LEFT OA WITH THE STEM AND HEAD. ON AN UNKNOWN DATE, THE PATIENT REPORTED PAIN AND VISITED THE HOSPITAL. THE PAIN CAUSE WAS SCIATICA, BUT THE X-RAYS SHOWED THAT THE OSTEOLYSIS AND ATROPHY OF THE PROXIMAL LATERAL FEMUR WERE OBSERVED. IN OCTOBER, THE REVISION SURGERY WILL BE PERFORMED. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Osteolysis; Pain; Unspecified Tissue Injury
MAUDE report 12624271 ↗MalfunctionMay 24, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION OF PINNACLE INSERT. INSERT WAS DISLOCATED FROM SHELL WITH OBVIOUS WEAR. LIKELY CAUSE IMPINGEMENT.
Patient problems: Muscular Rigidity; Pain
MAUDE report 11872407 ↗InjuryMar 11, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ORIGINAL TOTAL HIP REPLACEMENT (C-STEM) WAS CONDUCTED (B)(6) 2005 AT (B)(6) HOSPITAL. TODAY ((B)(6) 2021), THE ELITE PLUS LPW CUP WAS REMOVED AND A COMPETITOR CUP IMPLANTED. THE ORIGINAL ELITE HEAD WAS ALSO REMOVED AND A NEW ONE IMPLANTED. PATIENT DEMOGRAPHICS: UNKNOWN. REASON FOR REVISION: INSTABILITY. DFURTHER PATIENT ETAILS AND OPERATION NOTES UNAVAILABLE.
Patient problems: Joint Laxity
MAUDE report 11463721 ↗
Other Depuy (Ireland) products
All Depuy (Ireland) devices →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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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