NA 1172-25-000Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 10603295007616), received between Jul 9, 2018 and Mar 2, 2026 — classified as 12 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Loss of Osseointegration” (5 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• InjuryMar 2, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT THA FOR TRAUMA ON LEFT HIP JOINT WITH THE PRODUCTS IN QUESTION AT AROUND (B)(6) 2007. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. DURING HOSPITALIZATION FOR TREATMENT OF A FRACTURE IN ANOTHER AREA, SIGNIFICANT WEAR WAS FOUND ON THE CUP AND LINER USED IN THE LEFT HIP. THE AFFECTED AREA BY THE FRACTURE WAS NOT THE LEFT HIP, AND THE TREATMENT FOR THE FRACTURE WAS NOT RELATED TO THE LEFT HIP. DUE TO SEVERE BONE LOSS ON THE ACETABULAR SIDE, THE HOSPITAL COULD NOT PERFORM THE SCHEDULED REVISION SURGERY, AND THE PATIENT WILL BE REFERRED TO ANOTHER FACILITY. THE REVISION SCHEDULED FOR (B)(6) WAS CANCELED. NO FURTHER INFORMATION IS PROVIDED.

  Patient problems: Bone Notching

  MAUDE report 24489996 ↗
• MalfunctionFeb 16, 2026Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT BEFORE A TOTAL HIP ARTHROPLASTY SURGICAL PROCEDURE, WHEN THE SURGEON CHOSE TO USE THE CANCELLOUS BONE SCREW, THE PACKAGE WAS FOUND EMPTY. ANOTHER PACKAGE WAS OPENED AND THE SURGERY WAS PERFORMED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24344492 ↗
• InjurySep 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2003, THE PATIENT UNDERWENT AN INITIAL SURGERY VIA THA ON HIP JOINT WITH THE PRODUCTS IN QUESTION. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. AFTER THE SURGERY, IN EARLY 2025, THE INFECTED AREA WAS CLEANED BY DEBRIDEMENT, BUT THE CONDITION WAS NOT COMPLETELY CURED. SURGEON DECIDED AGAINST COMPLETE REMOVAL FOR THE TIME BEING, AND BECAUSE THE LINER WAS WORN, HE SAID HE WOULD MONITOR THE SITUATION AND CONSIDER REPLACING THE LINER.

  Patient problems: Unspecified Infection

  MAUDE report 22979359 ↗
• InjuryOct 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED (B)(6) 2001, THE PATIENT UNDERWENT A SURGERY VIA THA ON THE RIGHT SIDE. ON (B)(6) 2024, THE REVISION SURGERY WAS PERFORMED DUE TO CHRONIC INFECTION. ONLY THE FEMORAL SLEEVE WAS PRESERVED, AND ALL OTHER IMPLANTS WERE REMOVED, AND A CEMENT SPACER WAS INSTALLED. A TWO-STAGE OPERATION (REPLACEMENT) IS SCHEDULED.

  Patient problems: Unspecified Infection

  MAUDE report 20411950 ↗
• MalfunctionJan 23, 2024Fracture; Naturally Worn; Fracture; Naturally Worn

  IT WAS REPORTED THAT SCREW HEAD WAS DAMAGED DURING USE. WAS SURGERY DELAYED DUE TO THE REPORTED EVENT? UNKNOWN, WAS PROCEDURE SUCCESSFULLY COMPLETED? UNKNOWN, WERE FRAGMENTS GENERATED? UNKNOWN, IF YES, WERE THEY REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION? UNKNOWN, PATIENT STATUS/ OUTCOME / CONSEQUENCES NO, WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: UNKNOWN, IS THE PATIENT PART OF A CLINICAL STUDY UNKNOWN, (B)(4) DEVICE PROPERTY OF NONE, DEVICE IN POSSESSION OF NONE BY CHECKING THIS BOX I CERTIFY THAT ALL INFORMATION THAT ARE KNOWN/AVAILABLE HAS BEEN DISCLOSED. IF ANY NEW INFORMATION WILL BE MADE AVAILABLE, THE ADDITIONAL INFORMATION WILL BE SUBMITTED THROUGH CST. TRUE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18563104 ↗
• InjurySep 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2000, THE PRIMARY SURGERY WAS PERFORMED VIA THA WITH THE IMPLANTS IN QUESTION. AFTER THE SURGERY, THE PATIENT REPEATEDLY DISLOCATED. THE EVENT DATE IS UNKNOWN. THE REVISION SURGERY WAS PERFORMED ON (B)(6) 2023, TO REMOVE THE STEM, THE LINER AND THE SCREWS OF THE CUP. AFTER THE TRIAL, THE LINER, THE STEM AND THE HEAD WAS REPLACED. THE REASON FOR THE REVISION IS DISLOCATION DUE TO IMPINGEMENT. DOI: (B)(6) 2000. DOR: (B)(6) 2023. UNKNOWN HIP.

  Patient problems: Joint Laxity

  MAUDE report 17689346 ↗
• InjuryJul 2, 2020Unintended Movement; Migration; Unintended Movement; Migration

  THE PRIMARY SURGERY WAS PERFORMED ON (B)(6) 2002 VIA THA FOR THE PATIENT¿S RIGHT HIP JOINT. IT WAS REPORTED THAT THE REVISION SURGERY WAS PERFORMED ON (B)(6) 2020 BY REPLACING THE CUP (P/N: 124552000), THE LINER (P/N: 124012000), AND THE HEAD (P/N: 853824) DUE TO ACETABULAR SIDE¿S PAIN AND MIGRATION. A STEM (P/N: UNKNOWN) WAS REMAINED BECAUSE THERE WAS NO REMARK OF DEGENERATION. THE SURGERY WAS COMPLETED WITHOUT ANY SURGICAL DELAY. THE SURGEON THOUGHT THAT ONE OF THE FACTORS WAS INSUFFICIENCY OF REAMING FOR THE CUP. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Code Available; Pain

  MAUDE report 10224354 ↗
• InjuryJul 2, 2020Unintended Movement; Migration; Unintended Movement; Migration

  THE PRIMARY SURGERY WAS PERFORMED ON (B)(6) 2002 VIA THA FOR THE PATIENT¿S RIGHT HIP JOINT. IT WAS REPORTED THAT THE REVISION SURGERY WAS PERFORMED ON (B)(6) 2020 BY REPLACING THE CUP (P/N: 124552000), THE LINER (P/N: 124012000), AND THE HEAD (P/N: 853824) DUE TO ACETABULAR SIDE¿S PAIN AND MIGRATION. A STEM (P/N: UNKNOWN) WAS REMAINED BECAUSE THERE WAS NO REMARK OF DEGENERATION. THE SURGERY WAS COMPLETED WITHOUT ANY SURGICAL DELAY. THE SURGEON THOUGHT THAT ONE OF THE FACTORS WAS INSUFFICIENCY OF REAMING FOR THE CUP. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Code Available; Pain

  MAUDE report 10224339 ↗
• InjuryJan 30, 2020Loss of Osseointegration; Loss of Osseointegration

  THE PRIMARY SURGERY WAS PERFORMED ON (B)(6) 2004 VIA THA BY USING THE CUP (P/N: 960013000), THE LINER (P/N: 960019000), THE STEM (P/N: 900531210) WITH THE SLEEVE (P/N: 521465), THE HEAD (P/N: 152190051). IT WAS REPORTED THAT THE REVISION SURGERY WAS SCHEDULED TO BE PERFORMED ON (B)(6) 2020 BY REPLACING THE CUP DUE TO LOOSENING ACETABULAR SIDE.

  Patient problems: Inadequate Osseointegration; No Code Available

  MAUDE report 9647807 ↗
• InjuryJan 24, 2020Loss of Osseointegration; Loss of Osseointegration

  THE PATIENT WAS REVISED TO ADDRESS PAIN AND LOOSENING OF THE CUP AT THE BONE TO IMPLANT INTERFACE. DOI: (B)(6) 2000; DOR: (B)(6) 2020 ; RIGHT HIP,

  Patient problems: Inadequate Osseointegration; No Code Available; Pain

  MAUDE report 9629213 ↗
• InjuryAug 30, 2019Loss of Osseointegration; Loss of Osseointegration

  THE PRIMARY SURGERY WAS PERFORMED VIA THA (DATE OF SURGERY WAS UNKNOWN). IT WAS REPORTED THAT THE REVISION SURGERY WAS PERFORMED ON (B)(6) 2019 BY REPLACING THE CUP (P/N: 124552000), THE LINER (P/N: 123912500), THE HEAD (P/N: 152190052) DUE TO LOOSENING OF THE CUP CAUSED BY WEAR OF THE LINER, EXTENSIVE OSTEOLYSIS ON THE PATIENT¿S RIGHT ACETABULAR SIDE. HOWEVER, THERE WAS NO LOOSENING OF THE AML STEM NOR NO TRUNIONOSIS. THUS, THE CUP, THE LINER, 2 SCREWS (P/NS: 117225000, 117230000) WERE EXPLANTED, A CEMENTED CUP WAS INSERTED AFTER TRANSPLANTED BONE TO ACETABULUM, THE HEAD WAS REPLACED WITHOUT THE AML STEM WAS EXPLANTED. THE SURGERY WAS COMPLETED WITHOUT PROBLEM, AND IT WAS UNKNOWN WHETHER THERE WAS A SURGICAL DELAY OR NOT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Inadequate Osseointegration; No Code Available; Osteolysis

  MAUDE report 8951732 ↗
• MalfunctionAug 5, 2019Loss of Osseointegration; Osseointegration Problem; Loss of Osseointegration; Osseointegration Problem

  PATIENT FROM (B)(6) , HAD CALLED UP AND INFORMED THAT HE HAS UNDERGONE RIGHT HIP REPLACEMENT SURGERY IN THE YEAR 2007 AT (B)(6). HE SAID THAT AS HE WAS HAVING THE PAIN AND VISITED THE DOCTOR AND THE DR HAS SUGGESTED HIM TO UNDERGO A REVISION SURGERY BECAUSE OF SOME PROBLEM IN THE IMPLANT. THUS WANTS THE REVISION SURGERY TO DONE BY THE JOHNSON & JOHNSON COMPANY AND WANTS AN URGENT CALL BACK FOR THE SAME.

  Patient problems: Erosion; Hypersensitivity/Allergic reaction; Inadequate Osseointegration; No Code Available; Pain; Tissue Damage

  MAUDE report 8860593 ↗
• MalfunctionAug 5, 2019Loss of Osseointegration; Osseointegration Problem; Loss of Osseointegration; Osseointegration Problem

  PATIENT FROM (B)(6), HAD CALLED UP AND INFORMED THAT HE HAS UNDERGONE RIGHT HIP REPLACEMENT SURGERY IN THE YEAR 2007 AT (B)(6). HE SAID THAT AS HE WAS HAVING THE PAIN AND VISITED THE DOCTOR AND THE DR HAS SUGGESTED HIM TO UNDERGO A REVISION SURGERY BECAUSE OF SOME PROBLEM IN THE IMPLANT. THUS WANTS THE REVISION SURGERY TO DONE BY THE JOHNSON & JOHNSON COMPANY AND WANTS AN URGENT CALL BACK FOR THE SAME.

  Patient problems: Erosion; Hypersensitivity/Allergic reaction; Inadequate Osseointegration; No Code Available; Pain; Tissue Damage

  MAUDE report 8860134 ↗
• InjuryFeb 25, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT UNDERGONE TOTAL HIP REPLACEMENT AND EXPERIENCING PAIN, INFECTION AND CLICKING. HE INDICATED HE HAS HAD MULTIPLE SURGERIES SINCE HIS PRIMARY IN 2016. HE HAS NOW HAD THE HIP JOINT "REMOVED" AND IS BED BOUND.

  Patient problems: No Code Available; Pain; Unspecified Infection

  MAUDE report 8365967 ↗
• InjuryDec 15, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  REVISED DUE TO PAIN.

  Patient problems: Hearing Loss; Loss of Range of Motion; Memory Loss/Impairment; Pain

  MAUDE report 8167483 ↗
• InjuryDec 10, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  REVISION DUE TO INFECTION.

  Patient problems: Hypersensitivity/Allergic reaction; Infarction, Cerebral; Rash; Unspecified Infection

  MAUDE report 8146972 ↗
• MalfunctionJul 9, 2018Break; Break

  CANCELLOUS BONE SCREW 6.5 25MM CODE (B)(4), LOT: HM1330, Q-TY 1 PC. DURING PROCEDURE HALF OF CAP OF SCREW WAS BROKEN. NO PATIENT HARM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7670228 ↗