NA 1172-30-000Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 10603295007623), received between Jul 17, 2018 and Oct 9, 2024 — classified as 11 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Loss of Osseointegration” (6 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• 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 20412266 ↗
• InjuryAug 26, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE CUP WAS REMOVED DUE TO MALPOSITION. THE HEAD HAD WORN THE POLY DOWN OVER TIME.

  Patient problems: Joint Laxity

  MAUDE report 12373658 ↗
• InjuryMar 29, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) THE PATIENT UNDERWENT THE REVISION SURGERY BECAUSE SHE FELT PAIN SUDDENLY. DOI: UNKNOWN. DOR: (B)(6) 2021.

  Patient problems: Pain

  MAUDE report 11581454 ↗
• InjuryMar 2, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PRIMARY SURGERY WAS PERFORMED ON (B)(6) 2009 FOR THE PATIENT'S HIP JOINT. THE REVISION SURGERY WAS PERFORMED ON (B)(6) 2021. THE REASON OF THE REVISION SURGERY WAS SUDDEN PAIN. THE SURGEON HAD PREDICTED SOME PROBLEM CAUSED BY TRUNNIONOSIS, HOWEVER, MADE AN INCISION AND LOOKED AT THE AFFECTED AREA, THERE WAS NO METAL DEBRIS AT NECK AND HEAD, NO SIGN OF ARMD. THERE WAS NO LOOSENING. THE SURGEON COMMENTED THAT SURPRISINGLY, IT WAS FINE. HE DID NOT MENTION THE CAUSE OF PAIN. THE SURGEON REMOVED ALL IMPLANTS AND INSERTED NEW IMPLANTS (MANUFACTURED BY ANOTHER COMPANY). THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Pain

  MAUDE report 11398070 ↗
• MalfunctionSep 9, 2020Loss of Osseointegration; Loss of Osseointegration

  THE PRIMARY SURGERY WAS PERFORMED ON AN UNKNOWN DATE AT (B)(6) HOSPITAL. THE 1ST REVISION SURGERY WAS PERFORMED ON (B)(6) AT (B)(6) HOSPITAL. WHEN THE 1ST REVISION SURGERY, THE SURGEON PERFORMED GREAT TROCHANTER OSTEOTOMY AND JOINTED WITH A GREAT TROCHANTER GRIP, HOWEVER, THERE WAS A SUSPICION OF JOINT FAILURE. AND, THERE WAS ALSO SUSPICION OF LOOSENING OF THE CUP, THE PATIENT HAD BEEN UNDER FOLLOW-UP BY THE SURGEON. IT WAS REPORTED THAT THE PATIENT HAD A PAIN IN EARLY (B)(6) 2020, AND THE SURGEON CONFIRMED THE DISLOCATION OF THE HEAD FROM THE STEM¿S NECK BY X-RAY. THERE WAS NO CAUSE OF THE DISLOCATION LIKE IMPACT SHOCK. THE SURGEON THOUGHT THAT THE CORROSION OF NECK TRUNNION POINT CAUSED THE DISLOCATION. THE PATIENT CANNOT WALK DUE TO THE DISLOCATION. THE SURGEON PLANNED 2ND REVISION SURGERY BY REPLACING THE HEAD IF HE CAN HAVE HIS DESIRED IMPLANT, BUT IF THE IMPLANT CANNOT BE ENGAGED, HE WILL CONTINUE FOLLOW-UP FOR THE PATIENT BECAUSE REMOVING THE STEM CAUSES AN EXTENSIVE INVASIVE SURGERY FOR ADVANCED OLD AGE PATIENT AS (B)(6) YEARS. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Ambulation or Postural Difficulties; Inadequate Osseointegration; No Code Available; Pain

  MAUDE report 10511618 ↗
• MalfunctionSep 9, 2020Loss of Osseointegration; Loss of Osseointegration

  THE PRIMARY SURGERY WAS PERFORMED ON AN UNKNOWN DATE AT (B)(6) HOSPITAL. THE 1ST REVISION SURGERY WAS PERFORMED ON (B)(6) AT (B)(6) HOSPITAL. WHEN THE 1ST REVISION SURGERY, THE SURGEON PERFORMED GREAT TROCHANTER OSTEOTOMY AND JOINTED WITH A GREAT TROCHANTER GRIP, HOWEVER, THERE WAS A SUSPICION OF JOINT FAILURE. AND, THERE WAS ALSO SUSPICION OF LOOSENING OF THE CUP, THE PATIENT HAD BEEN UNDER FOLLOW-UP BY THE SURGEON. IT WAS REPORTED THAT THE PATIENT HAD A PAIN IN (B)(6) 2020, AND THE SURGEON CONFIRMED THE DISLOCATION OF THE HEAD FROM THE STEM¿S NECK BY X-RAY. THERE WAS NO CAUSE OF THE DISLOCATION LIKE IMPACT SHOCK. THE SURGEON THOUGHT THAT THE CORROSION OF NECK TRUNNION POINT CAUSED THE DISLOCATION. THE PATIENT CANNOT WALK DUE TO THE DISLOCATION. THE SURGEON PLANNED 2ND REVISION SURGERY BY REPLACING THE HEAD IF HE CAN HAVE HIS DESIRED IMPLANT, BUT IF THE IMPLANT CANNOT BE ENGAGED, HE WILL CONTINUE FOLLOW-UP FOR THE PATIENT BECAUSE REMOVING THE STEM CAUSES AN EXTENSIVE INVASIVE SURGERY FOR ADVANCED OLD AGE PATIENT AS (B)(6). NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Ambulation or Postural Difficulties; Inadequate Osseointegration; No Code Available; Pain

  MAUDE report 10511545 ↗
• InjuryMay 4, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RECEIVED A X-RAY OF A POST THR PATIENT, SEEMS A BROKEN STEM FROM THE NECK AND LOOKS JNJ CORAIL PINNACLE PRODUCT. PATIENT WAS COMPLAINING SEVERE PAIN IN RIGHT SIDE OF HIP, INABILITY TO STAND AND INABILITY TO WALK. PATIENT ALSO INFORMED SURGEON THAT HE GOT FALLEN DURING HIS ROUTINE WORK. PATIENT ALSO INFORMED TO SURGEON THAT HIS RIGHT HIP WAS ALREADY OPERATED IN 2018 DUE TO AVN BY ANY OTHER SURGEON FROM THE PATNA, & RT HIP WAS IMPLANTED WITH JNJ PRODUCT. AND PATIENT HAS ALSO REPORTED THAT HE IS HAVING PAIN IN HIS RT HIP (OPERATED SITE) AND GETTING SOME UNUSUAL SOUND SINCE LAST ONE YEAR.

  Patient problems: Limited Mobility Of The Implanted Joint; No Code Available; Pain

  MAUDE report 10022558 ↗
• 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 8951738 ↗
• 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) HOSPITAL, (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 8860158 ↗
• 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 8365969 ↗
• InjuryJan 4, 2019Biocompatibility; Biocompatibility

  REVISION DUE TO PAIN AND ELEVATED METAL IONS.

  Patient problems: No Code Available; Pain; Test Result

  MAUDE report 8217280 ↗
• 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 8146997 ↗
• InjuryNov 28, 2018Loose or Intermittent Connection; Loss of Osseointegration; Loose or Intermittent Connection; Loss of Osseointegration

  LITIGATION ALLEGES PSEUDOTUMOR AND LOOSENING. DOI: (B)(6) 2005 - DOR: (B)(6) 2007 (RIGHT HIP).

  Patient problems: Injury; Limited Mobility Of The Implanted Joint; No Code Available; Pain; Tissue Damage

  MAUDE report 8109969 ↗
• InjuryNov 28, 2018Loose or Intermittent Connection; Loss of Osseointegration; Loose or Intermittent Connection; Loss of Osseointegration

  LITIGATION ALLEGES PSEUDOTUMOR AND LOOSENING. DOI: (B)(6) 2005 - DOR: (B)(6) 2007 (RIGHT HIP).

  Patient problems: Injury; Limited Mobility Of The Implanted Joint; No Code Available; Pain; Tissue Damage

  MAUDE report 8109966 ↗
• MalfunctionAug 27, 2018Break; Break

  CANCELLOUS BONE SCREW 6.5 30 MM, CODE (B)(4), LOT HM1711 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 7820201 ↗
• MalfunctionJul 17, 2018Fracture; Fracture

  CANCELLOUS BONE SCREW 6.5X30MM CODE 117230000 LOT HM7102 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 7694295 ↗