PINNACLE GRIPTION 1217-32-056Recalls & reported problems

Summary

The FDA's MAUDE database contains 192 adverse event reports that list this exact device (DI 10603295010326), received between May 2, 2014 and Sep 18, 2026 — classified as 176 injuries, 16 malfunctions.

The most frequently reported specific device problem is “Osseointegration Problem” (27 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 25 most recent of 192 reports, in the reporter's own words as published by the FDA.

• InjurySep 18, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that patient is infected. Taking out all hip implants and converting to a spacer.Affected side: Left.

  Patient problems: Unspecified Infection

  MAUDE report 50824689 ↗
• InjurySep 10, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that patient was revised due to Instability.DOI-UnknownDOR-(b)(6) 2026Affected side-Left

  Patient problems: Joint Laxity

  MAUDE report 50715900 ↗
• InjuryJun 17, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS REVISED DUE TO PAIN. DOI: (B)(6) 2026. DOR: (B)(6) 2026. AFFECTED SIDE: UNKNOWN HIP.

  Patient problems: Pain

  MAUDE report 25531780 ↗
• InjuryMay 5, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS REVISED DUE TO PAIN. DOI-UNKNOWN. DOR- (B)(6) 2026. AFFECTED SIDE-RIGHT HIP.

  Patient problems: Pain

  MAUDE report 25085674 ↗
• InjuryApr 17, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT IT WAS AN INFECTION CASE. AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 24911273 ↗
• InjuryApr 1, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD INFECTION DUE TO WHICH ALL THE COMPONENTS WERE EXPLANTED AND SPACER IMPLANTED. DOI- (B)(6) 2026, DOR- (B)(6) 2026, AFFECTED SIDE- RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 24753429 ↗
• InjuryFeb 3, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THERE WAS A REVISION SURGERY DUE TO INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 24247961 ↗
• InjuryJan 20, 2026Migration

  VOLUNTARY REPORT RECEIVED (MW5178318). I AM REPORTING SERIOUS HARM AND PRODUCT TRACEABILITY ISSUES INVOLVING HIP IMPLANTS USED IN TWO SEPARATE SURGERIES THAT APPEAR TO INVOLVE JOHNSON & JOHNSON/DEPUY SYNTHES DEVICES. BOTH SURGERIES RESULTED IN COMPLICATIONS, PAIN, AND DISABILITY, AND IN BOTH CASES THE IMPLANTS LACKED PROPER IDENTIFICATION OR TRACEABLE UNIQUE DEVICE IDENTIFIER (UDI) INFORMATION. FIRST SURGERY (B)(6) 2024 ((B)(6) HOSPITAL, MD): A JOHNSON & JOHNSON/DEPUY REPRESENTATIVE NAMED (B)(6) WAS PRESENT IN THE OPERATING ROOM. THE SURGEON SIGNED OFF ON THE IMPLANT EVEN THOUGH THE IMPLANT SHEET DID NOT CONTAIN SPECIFIC SERIAL OR UNIQUE DEVICE IDENTIFIER (UDI) NUMBERS. THE IMPLANT HAD NO IDENTIFIABLE MARKINGS, MAKING IT COMPLETELY UNTRACEABLE. THIS VIOLATES STANDARD FOOD AND DRUG ADMINISTRATION (FDA) AND HOSPITAL TRACEABILITY RULES. POST-OPERATIVELY, I EXPERIENCED PAIN, INSTABILITY, AND NUMBNESS IN MY LEG. WHEN LATER REVISION SURGERY WAS PERFORMED, THE IMPLANT WAS FOUND TO BE AT A 36-DEGREE ANGLE, IMPROPERLY FITTED,AND FRACTURED, CONFIRMING MECHANICAL AND QUALITY FAILURE. SECOND (REVISION) SURGERY (B)(6) 2025 ((B)(6) HOSPITAL, (B)(6)): THE REVISION SURGEON, DR. (B)(6), DOCUMENTED

  Patient problems: Joint Laxity; Loss of Range of Motion; Numbness; Pain

  MAUDE report 24122209 ↗
• InjuryJan 14, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DISLOCATION AND FRACTURE. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT HIP.

  Patient problems: Bone Fracture(s)

  MAUDE report 24069383 ↗
• InjuryJan 12, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THERE WAS INFECTION IN PATIENT'S HIP. IMPLANTS WERE EXTRACTED AND A TEMPORARY SPACER WAS IMPLANTED TO REMOVE INFECTION. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 24042021 ↗
• InjuryDec 31, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT WAS UNSTABLE WITH DISLOCATION. THE PATIENT UNDERWENT A REVISION PROCEDURE WHERE THE CUP, LINER, FEMORAL HEAD AND ONE (1) SCREW WERE REMOVED AND REPLACED. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Laxity

  MAUDE report 23935289 ↗
• InjuryDec 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS INFECTED. THE IMPLANTS WERE REMOVED AND PROSTALAC WAS INSERTED. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 23804263 ↗
• InjuryOct 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT REMOVAL DUE TO INFECTION. AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 23367146 ↗
• InjurySep 4, 2025Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO CUP WAS LOOSE DUE TO POOR BONE QUALITY. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT HIP.

  Patient problems: Inadequate Osseointegration

  MAUDE report 22965863 ↗
• InjuryJul 10, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED FOR DISLOCATED RIGHT HIP. NO SURGICAL DELAY. REPOSITIONED CUP. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Insufficient Information

  MAUDE report 22466944 ↗
• InjuryJun 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S IMPLANTS REMOVED DUE TO INFECTED HIP, PLACED PROSTHETIC, STEM, AND ALL POLY LINER. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 22358714 ↗
• InjuryMay 7, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT THE REVISION OF A C-STEM PINNACLE WAS DONE DUE TO DISLOCATION. THE SURGEON DESCRIBED THE CUP AS TOO OPEN/STEEP WITH EXCESSIVE INCLINATION. THE LINER AND CERAMIC 36 +5 HEAD WERE REMOVED. THE CUP WAS CONVERTED TO PINNACLE DM AND A REVISION 28+8.5 CERAMIC HEAD WAS IMPLANTED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO SURGICAL DELAY. PRIMARY: (B)(6) 2025, REVISION: (B)(6) 2025, AFFECTED SIDE: RIGHT SIDE.

  Patient problems: Joint Dislocation

  MAUDE report 21976945 ↗
• InjuryApr 25, 2025Osseointegration Problem; Osseointegration Problem

  PATIENT WAS REVISED DUE TO LOOSENING OF THE CUP AT NON-CEMENTED INTERFACE. PATIENT SUFFERED A FALL 2 WEEK POST OP AND A REFRIGERATOR FELL ON HIM. NO SURGICAL DELAY. DOI: (B)(6) 2024. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT HIP.

  Patient problems: Fall; Inadequate Osseointegration

  MAUDE report 21908525 ↗
• InjuryApr 1, 2025Osseointegration Problem; Osseointegration Problem

  PATIENT WAS REVISED DUE TO LOOSENING OF ACETABULUM OF RIGHT HIP. THERE WAS NO SURGICAL DELAY. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Inadequate Osseointegration

  MAUDE report 21740290 ↗
• InjuryMar 28, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO LINER DISSOCIATION. IT IS UNKNOWN IF THERE WAS ANY SURGICAL DELAY.AFFECTED SIDE: RIGHT HIP.

  Patient problems: Insufficient Information

  MAUDE report 21718539 ↗
• InjuryMar 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD A TOTAL HIP ON (B)(6) 2024. PATIENT BECAME INFECTED AND HAD A HEAD & LINER EXCHANGE ON (B)(6) 2025. PATIENT RETURNED WITH ANOTHER INFECTION FOR A FULL REVISION. NO SURGICAL DELAY AND NO ADVERSE CONSEQUENCES AFFECTING THE PATIENT BECAUSE OF THE REPORTED EVENT. NO FURTHER INFORMATION WAS PROVIDED FOR REPORTING. DOI: (B)(6) 2025, DOR: (B)(6) 2025, AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 21552749 ↗
• InjuryMar 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT IMPLANTS WERE REMOVED DUE TO POSSIBLE INFECTION. THERE WAS NO SURGICAL DELAY. IT WAS FURTHER REPORTED THAT INFECTION WAS UNABLE TO BE DETERMINED. AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 21524799 ↗
• InjuryFeb 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT CORAIL PINNACLE REVISION DUE TO INFECTION. HARDWARE WAS REMOVED.

  Patient problems: Unspecified Infection

  MAUDE report 21355068 ↗
• InjuryJan 8, 2025Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION CUP SURGERY DUE TO PAIN AND NON-CEMENTED LOOSENING OF THE ACETABULAR CUP. THE PATIENT WAS REVISED TO A MULTIHOLE PINNACLE CUP AND 40 MM LINER AND HEAD FOR STABILITY. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2024, DOR: (B)(6)2024, AFFECTED SIDE: LEFT HIP.

  Patient problems: Inadequate Osseointegration; Pain

  MAUDE report 21102203 ↗
• InjuryDec 31, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT UNDERWENT REVISION HIP SURGERY AND RENEWAL OF ALL HARDWARE DUE TO INFECTION. SURGEON REPLACED ALL REMOVED HARDWARE WITH A PROSTALAC 240 STEM AND 56*40 POLY LINER AND 40. 1.5 CERAMIC HEAD. THERE WAS NO SURGICAL DELAY. DOI- UNKNOWN. DOR- (B)(6) 2023. AFFECTED SIDE- LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 21047838 ↗