PINNACLE GRIPTION 1217-30-048Recalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 10603295009962), received between Mar 20, 2018 and Apr 6, 2026 — classified as 21 injuries, 2 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 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• InjuryApr 6, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON JANUARY 18, 2026, THE PATIENT UNDERWENT THA. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. ON (B)(6) 2026, THE PATIENT SUFFERED HIP DISLOCATION. THE DISLOCATION WAS SUCCESSFULLY REDUCED MANUALLY. SINCE THERE WERE NO PROBLEMS WITH THE PLACEMENT OF THE IMPLANTS, THE SURGEON DECIDED TO MONITOR THE SITUATION FOR A WHILE. ACCORDING TO THE SURGEON, THE PATIENT FELL SHORTLY AFTER THE THA SURGERY AND SUFFERED GREATER TROCHANTERIC FRACTURES. THE FRACTURES WERE TREATED WITH CABLES. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Fall; Joint Laxity

  MAUDE report 24794178 ↗
• InjuryJan 23, 2026Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PRESENTED SIGNS OF INFECTION DURING COVID. DOI: (B)(6) 2019. DOR: (B)(6) 2026. AFFECTED SIDE: UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 24162447 ↗
• InjurySep 8, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2025, THE PATIENT UNDERWENT AN INITIAL SURGERY VIA THA FOR OA ON HIP JOINT WITH THE PRODUCTS IN QUESTION. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. AFTER THE SURGERY, THE SALES REP WAS INFORMED THAT THE PATIENT IS SUSPECTED OF HAVING A DISLOCATION AND INFECTION, THEREFOR REVISION SURGERY IS SCHEDULED FOR (B)(6) 2025. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Unspecified Infection

  MAUDE report 22998290 ↗
• InjuryJul 1, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO INFECTED LEFT HIP. NO SURGICAL DELAY. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 22375720 ↗
• InjuryNov 27, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO PAIN. THERE WAS NO SURGICAL DELAY. DOI: UNKNOWN, DOR: (B)(6) 2023 AFFECTED SIDE: RIGHT HIP.

  Patient problems: Pain

  MAUDE report 18212790 ↗
• InjurySep 11, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PERSISTENT INFECTION AFTER MULTIPLE WASH OUT OF HEAD AND LINER EXCHANGE ATTEMPTS. SURGEON REMOVED CUP, LINER, STEM AND HEAD. SURGEON THEN WASHED THE PATIENT OUT AN PLACED AN ANTIBIOTIC SPACER AND CEMENTED IN A POLY LINER WITH NEW CERAMIC HEAD. NO SURGICAL DELAY. DOI: (B)(6) 2022. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 17725531 ↗
• InjuryJun 7, 2023Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE ABOUT 3,4 YEARS AGO, THE PRIMARY SURGERY WAS PERFORMED VIA THA. THE REVISION SURGERY IS SCHEDULED ON AN UNKNOWN DATE DUE TO THE LOOSENING OF THE CUP.

  Patient problems: Inadequate Osseointegration

  MAUDE report 17081073 ↗
• InjuryMay 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO HIP DISLOCATION AND WAS INFECTED. ALL ACETABULAR COMPONENTS WERE REMOVED AND AN ANTIBIOTIC SPACER WAS PLACED. DOI: (B)(6) 2023. DOR: (B)(6) 2023. AFFECTED SIDE : UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 16930662 ↗
• InjuryDec 20, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  LINER MECHANISM FAILED AND DISENGAGED. THIS CAUSED LINER TO BREAK INTO MANY PIECES. THE CUP AND SCREWS WERE REMOVED. STEM WAS RETAINED. DOI: (B)(6) 2015, DOR: (B)(6) 2021, AFFECTED SIDE: LEFT HIP.

  Patient problems: Insufficient Information

  MAUDE report 13047670 ↗
• InjuryJul 19, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD RIGHT TOTAL HIP REVISION RELATED TO INFECTION. DOI: (B)(6) 2021, DOR: (B)(6) 2021, RIGHT HIP.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 12192388 ↗
• InjuryJul 12, 2021Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT THA. THE PATIENT RECEIVED A REVISION TO TREAT CUP LOOSENING ON (B)(6) 2021. THE SUP, HEAD, LINER AND ACETABULAR SCREWS WERE REMOVED.

  Patient problems: Inadequate Osseointegration

  MAUDE report 12151009 ↗
• InjuryMay 20, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE SURGEON FELT THAT THE HIP WAS UNSTABLE TO REMOVE THE ACETABULUM COMPONENTS AND REVISED TO A DUAL MOBILITY CONSTRUCT. NO SURGICAL DELAY. DOI: (B)(6), 2020. DOR: (B)(6) 2021. LEFT HIP.

  Patient problems: Joint Laxity

  MAUDE report 11858024 ↗
• InjurySep 16, 2020Loss of Osseointegration; Loss of Osseointegration

  THE PATIENT'S CUP WAS REVISED TO ADDRESS THE LOOSENING OF THE ACETABULAR COMPONENT. THE CUP CONSTRUCT WAS REMOVED AND RE PREPPED FOR A LARGER GRIPTION MULTIHOLE CUP. HEADSIZE AND OFFSET WERE ALSO INCREASED. THE STEM REMAINED. I HAVE NO FURTHER INFORMATION. DOI: (B)(6) 2020. DOR: (B)(6) 2020; LEFT HIP.

  Patient problems: Inadequate Osseointegration; No Code Available

  MAUDE report 10540014 ↗
• InjuryMay 21, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO INFECTION AND LOOSENING AT AN UNKNOWN COMPONENT AT BONE TO IMPLANT INTERFACE. DOI: (B)(6) 2019; DOR: (B)(6) 2020; LEFT HIP.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 10079863 ↗
• InjuryMar 12, 2020Loss of Osseointegration; Loss of Osseointegration

  THE PATIENT WAS REVISED TO ADDRESS DISLOCATED HIP. DOI: (B)(6) 2020; DOR: (B)(6) 2020; AFFECTED SIDE: LEFT HIP.

  Patient problems: Inadequate Osseointegration; No Code Available

  MAUDE report 9823786 ↗
• MalfunctionNov 6, 2019Difficult to Remove; Device-Device Incompatibility; Difficult to Remove; Device-Device Incompatibility

  WHILE THE SURGICAL TEAM WAS THREADING THE CUP TO THE IMPACTOR, THE PINNACLE CUP WAS APPARENTLY FUSED TO THE IMPACTOR. THEREFORE IT WAS IMPOSSIBLE TO REMOVE THE CUP FROM THE IMPACTOR. WHEN DOING SO, THE SURGEON SAID HE FELT SOMETHING BREAK, PROBABLY THE IMPACTOR. PATIENT STATUS/ OUTCOME / CONSEQUENCES --> NO.

  Patient problems: Not Applicable

  MAUDE report 9286863 ↗
• MalfunctionOct 10, 2019Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT WHITE FOREIGN SUBSTANCE WAS ADHERED ON THE SIDE OF THE CUP (P/N: 121730048) WHEN IT WAS OPENED THE PACKAGE FOR USING THE CUP DURING THE THA SURGERY ON (B)(6) 2019. IT WAS ATTEMPTED TO REMOVE THE WHITE FOREIGN SUBSTANCE HOWEVER IT COULD NOT. THIS MEDICAL CASE THAT WAS REQUIRED A MULTI-HOLE CUP, MOREOVER, IT WAS UNABLE TO USE A LARGER CUP. THEREFORE, THE SURGEON USED THE CUP IN QUESTION UNAVOIDABLY. THE SURGERY WAS COMPLETED WITHIN A 30 MINUTES SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE. THERE WAS A REQUEST THAT THE CUSTOMER WOULD LIKE TO KNOW WHAT THE WHITE FOREIGN SUBSTANCE WAS. WE WOULD LIKE YOU TO INFORM US ABOUT THE POSSIBILITY OF ADHESION DURING THE WORK PROCESS, THE POSSIBLE CAUSES OF WHITE FOREIGN SUBSTANCE, THE POSSIBILITY OF WHETHER THERE WAS SOMETHING THAT WAS LIKELY TO BECOME THE WHITE FOREIGN SUBSTANCE IN THE PACKAGE.

  Patient problems: Not Applicable

  MAUDE report 9175359 ↗
• InjuryJul 10, 2019Loss of Osseointegration; Loss of Osseointegration

  IT WAS REPORTED THAT THE CUP WAS REVISED. THERE WAS LOOSENING OF CUP AT BONE TO IMPLANT INTERFACE. NO SURGICAL DELAY. DOI: (B)(6) 2019. DOR: (B)(6) 2019. LEFT HIP.

  Patient problems: Inadequate Osseointegration; No Code Available

  MAUDE report 8777202 ↗
• InjuryFeb 14, 2019Loss of Osseointegration; Osseointegration Problem; Loss of Osseointegration; Osseointegration Problem

  LITIGATION ALLEGES PAIN, HIP INFECTION, SCARS, DISFIGUREMENT, EMOTIONAL DISTRESS, SUFFERING AND MULTIPLE ADDITIONAL SURGERIES. DOI: (B)(6) 2018 (CUP, LINER, SCREW, HOLE, STEM). DOI: (B)(6) 2018 (HEAD). DOR: (B)(6) 2019. AFFECTED SIDE: LEFT HIP.

  Patient problems: Deformity/ Disfigurement; Distress; Inadequate Osseointegration; No Code Available; Pain; Scar Tissue; Unspecified Infection

  MAUDE report 8339047 ↗
• InjuryJul 26, 2018Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO LOOSENING FROM A FALL. DOI: (B)(6) 2015; DOR: (B)(6) 2018; RIGHT HIP.

  Patient problems: Fall; Inadequate Osseointegration; Not Applicable

  MAUDE report 7721927 ↗
• InjuryJun 4, 2018Loss of Osseointegration; Loss of Osseointegration

  DER STATED THAT THE PATIENT FELL. RIPPED OUT THE ACETABULAR CUP. IT WAS ALSO REPORTED THAT THE CUP AND STEM WERE LOOSENED AT THE BONE TO IMPLANT INTERFACE. DOI: (B)(6) 2018; DOR: (B)(6) 2018; RIGHT HIP.

  Patient problems: Fall; Inadequate Osseointegration; Not Applicable

  MAUDE report 7565686 ↗
• InjuryMay 23, 2018Loose or Intermittent Connection; Loose or Intermittent Connection

  THE PATIENT WAS REVISED TO ADDRESS PAIN AND LOOSENING OF THE CUP AT THE BONE TO IMPLANT INTERFACE. IT WAS ALSO INDICATED THAT THE SURGEON REMOVED THE CUP, LINER, AND SCREWS WITHIN GRIPTION MULTI HOLE CUP AND CHANGED FEMORAL HEAD. DOI: (B)(6) 2016; DOR: (B)(6) 2018; LEFT HIP. NO SURGICAL DELAY.

  Patient problems: Inadequate Osseointegration; Pain

  MAUDE report 7536297 ↗
• InjuryMar 20, 2018Loss of Osseointegration; Loss of Osseointegration

  PATIENT WAS REVISED TO ADDRESS FRACTURE THROUGH THE MEDIAL WALL, DISLOCATED AND LOOSENING AT THE BONE TO IMPLANT INTERFACE. TWO SCREWS WERE REMOVED INTACT AND THE SHELL HAD VERY LITTLE BONE IN GROWTH. DOI: (B)(6) 2013; DOR: (B)(6) 2018; LEFT HIP.

  Patient problems: Bone Fracture(s)

  MAUDE report 7352296 ↗