NA 1018-11-000Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 10603295001324), received between Oct 16, 2017 and May 29, 2026 — classified as 18 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (4 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, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• InjuryMay 29, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAS ECCENTRIC POLY WEAR WITH A FEELING OF INSTABILITY. DUE TO INABILITY TO USE A HEAD LARGER THAN A 32MM, THE SURGEON WAS REMOVING THE CUP, LINER AND HEAD IN ORDER TO GIVE HERE AN EMPHASYS CUP WITH DM CONSTRUCT. DOI: UNKNOWN. DOR: (B)(6) 2026. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Laxity

  MAUDE report 25333292 ↗
• InjuryOct 23, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING INSTABILITY AND DISLOCATION DUE TO POLY LINER WEAR. THE LINER AND HEAD WERE REMOVED. ORIGINAL IMPLANTATION DATE UNKNOWN. NO PATIENT CONSEQUENCE. NO SURGICAL DELAY. DOI: UNKNOWN, DOR: (B)(6) 2025, AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 23366934 ↗
• InjurySep 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO PAIN. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Pain

  MAUDE report 22954854 ↗
• InjuryMay 28, 2025Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE PATIENT HAD POLY AND HEAD EXCHANGE FOR WEAR. DATE OF IMPLANTATION WAS UNKNOWN BUT THOUGHT TO BE EARLY 1990S. THERE WERE NO BROKEN INSTRUMENTS OR DELAYS. AFFECTED SIDE: LEFT HIP.

  Patient problems: Insufficient Information

  MAUDE report 22097005 ↗
• InjuryJan 13, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT WAS REVISED WITH HEAD AND LINER SWAP DUE TO DISLOCATION. IMPLANTS BEEN IN FOR 30 YEARS. SURGICAL DELAY UNKNOWN. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. NO FURTHER INFORMATION WAS PROVIDED. DOI: UNKNOWN. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 21139338 ↗
• InjuryJun 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED INDICATES THAT THERE WAS NO SURGICAL DELAY.

  Patient problems: Pain

  MAUDE report 19607330 ↗
• InjuryApr 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED STATES THAT THERE WAS NO SURGICAL DELAY.

  Patient problems: Pain

  MAUDE report 19134323 ↗
• InjuryJan 30, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED STATES THAT THERE WAS NO SURGICAL DELAY.

  Patient problems: Pain

  MAUDE report 18608010 ↗
• InjuryJan 20, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT PATIENT WAS DISLOCATED AND EXPLANTED 28+0 FEMORAL HEAD AND IMPLANTED 28 +15.5 FEMORAL HEAD. NO FURTHER INFORMATION ON THIS CASE. THIS CASE. DOI: (B)(6) 1996. DOR: (B)(6) 2022; AFFECTED SIT: RIGHT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 13306363 ↗
• InjuryNov 18, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT PATIENT WAS DISLOCATING WITH A DEPUY STEM/ COMPETITOR CUP CONFIGURATION. THE HEAD AND LINER WERE REMOVED AND A CONSTRAINED LINER AND NEW LARGE TAPER HEAD WERE IMPLANTED. ORIGINAL IMPLANT DATE UNKNOWN. DOI: UNKNOWN. DOR: (B)(6) 2020; AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Dislocation; No Code Available

  MAUDE report 10861874 ↗
• InjuryMar 1, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT: (B)(6). CLINICAL NOTIFICATION RECEIVED FOR REVISION DUE TO PAIN AND POLYWEAR. DOI: (B)(6) 1992; DOR: (B)(6) 2018, (RIGHT HIP). HEAD AND LINER REVISED. PLEASE NOTE, THE ONLY THE FEMORAL HEAD WILL BE CAPTURED ON THIS PC AS THE LINER WAS COMPETITOR PRODUCT.

  Patient problems: No Code Available; Pain

  MAUDE report 8382433 ↗
• InjuryOct 12, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT REVISED DUE TO HIP PAIN.

  Patient problems: No Code Available; Pain

  MAUDE report 7961579 ↗
• InjuryAug 3, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT CONTACTED DEPUY TO REPORT PROBLEMS WITH IMPLANTS. ON (B)(6) 2010 THE REASON FOR REVISION SURGERY WAS DETERMINED. UPON RECEIPT OF MEDICAL RECORDS ON 6/3/2010 IT WAS CONFIRMED THAT DEPUY PRODUCTS WERE IMPLANTED IN THE RIGHT HIP AT THE ORIGINAL SURGERY ON (B)(6) 1996. PATIENT WAS REVISED ON (B)(6) 2008 TO ADDRESS ACETABULAR LOOSENING AND OSTEOLYSIS. DOI: (B)(6) 1996; DOR: (B)(6) 2008; (RIGHT SIDE). UPDATE:LITIGATION PAPERS RECEIVED. THERE IS NO NEW ADDITIONAL INFORMATION THAT WOULD AFFECT THE INVESTIGATION. UPDATE 08 JUN 2018. WPC (B)(4) HAS BEEN RE-OPENED UNDER (B)(4) DUE TO RECEIPT OF PINNACLE PPF RECORD. LITIGATION ALLEGES METAL WEAR AND METALLOSIS CONFIRMED IN MEDICAL RECORDS. ADDED MANUFACTURING DATE AND LAWYER FIRM AS WELL.

  Patient problems: No Code Available; Osteolysis; Tissue Damage

  MAUDE report 7747689 ↗
• InjuryJul 5, 2018Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE PATIENT HAD A COMPETITOR ACETABULAR LINER REVISED, FEMORAL HEAD WAS ALSO EXCHANGE DUE TO PAIN AND POLY WEAR. PATIENT HAD A PRIMARY HIP DONE IN 1988 AND ACETABULAR REVISION IN 1993 TO A COMPETITOR REVISION MULTI-HOLE CUP. AML STEM PUT IN 1988 WAS WELL FIXED. DOI: 1993; DOR: (B)(6) 2018; LEFT HIP.

  Patient problems: Pain

  MAUDE report 7663448 ↗
• InjuryApr 12, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS REVISED TO ADDRESS POLY WEAR. ADDITIONAL INFORMATION RECEIVED INDICATED THE PATIENT HAD PAIN. DOI: UNKNOWN; DOR: (B)(6) 2018; RIGHT HIP.

  Patient problems: Not Applicable; Pain

  MAUDE report 7424622 ↗
• InjuryMar 21, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  FAILED BIPOLAR HIP. PATIENT CONSEQUENCE? : UNKNOWN. IS THE INFORMATION BEING SUBMITTED FOR THIS COMPLAINT ALL THE DETAILS THAT ARE KNOWN/AVAILABLE REGARDING THIS EVENT? : YES.

  Patient problems: Pain

  MAUDE report 7358722 ↗
• InjuryOct 27, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS REVISED TO ADDRESS PAINFUL HIP.

  Patient problems: Pain

  MAUDE report 6983519 ↗
• InjuryOct 16, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS REVISED TO ADDRESS INSTABILITY AND PAIN.

  Patient problems: Pain

  MAUDE report 6951341 ↗