PINNACLE GRIPTION 1217-30-044Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 10603295009948), received between Sep 22, 2017 and Sep 24, 2026 — classified as 15 injuries, 1 malfunction.

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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• InjurySep 24, 2026Adverse Event Without Identified Device or Use Problem

  Patient was revised due to infection.DOI: Unknown.DOR: (b)(6) 2026.Affected Side: Unknown.

  Patient problems: Unspecified Infection

  MAUDE report 50889087 ↗
• MalfunctionFeb 20, 2026Device-Device Incompatibility

  IT WAS REPORTED THAT DURING A TOTAL HIP REPLACEMENT SURGERY, THE SURGEON INTENDED TO USE A PINNACLE SHELL; A TRIAL IMPLANT OF THE SELECTED SIZE FIT, BUT THE CORRESPONDING ACTUAL IMPLANT DID NOT MATCH WHEN OPENED, REQUIRING A DIFFERENT SHELL SIZE AFTER RE-TRIALING. SURGERY WAS NOT DELAYED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. NO FRAGMENTS WERE GENERATED. NO PATIENT DAMAGE OR CONSEQUENCES WERE REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24402782 ↗
• InjuryDec 22, 2025Noise, Audible; Migration; Noise, Audible; Migration

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

  Patient problems: Ambulation or Postural Difficulties; Cellulitis; Discomfort; Foreign Body Reaction; Pain; Physical Asymmetry

  MAUDE report 23866518 ↗
• InjuryApr 3, 2023Osseointegration Problem; Migration; Osseointegration Problem; Migration

  PATIENT WAS REVISED DUE TO LOOSENING OF THE CUP AND SCREWS AT BONE TO IMPLANT INTERFACE. PATIENT DEVELOPED A LARGE CYST IN THEIR SUPERIOR ACETABULUM NEAR THE ILIUM. DUE TO THIS, THE CUP AND SCREWS SHIFTED CAUSING PAIN TO THE PATIENT. NO ADDITIONAL INFORMATION. DOI: (B)(6) 2022, DOR: (B)(6) 2023, AFFECTED SIDE: RIGHT HIP.

  Patient problems: Cyst(s); Inadequate Osseointegration; Pain

  MAUDE report 16663143 ↗
• InjuryJan 5, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION. THERE WAS NO SURGICAL DELAY. DOI: UNKNOWN, DOR: (B)(6) 2022, AFFECTED SIDE: UNKNOWN HIP.

  Patient problems: Unspecified Infection

  MAUDE report 16103531 ↗
• InjuryDec 19, 2022Device Dislodged or Dislocated; Naturally Worn; Device Dislodged or Dislocated; Naturally Worn

  A PATIENT WITH AN SROM/PINNACLE BANTAM CONSTRUCT RETURNED FOR A REVISION HIP PROCEDURE AS A RESULT OF A DISASSOCIATED ALTRX LINER. THE CERAMIC FEMORAL HEAD IMPLANT WAS RUBBING AGAINST THE INSIDE OF THE PINNACLE SHELL.

  Patient problems: Insufficient Information

  MAUDE report 16003685 ↗
• InjurySep 14, 2022Device Dislodged or Dislocated; Naturally Worn; Device Dislodged or Dislocated; Naturally Worn

  DISLOCATION OF POLYETHYLENE, WHEN THE HEAD CONTACTED WITH THE CUP, PART OF THE CUP WAS ATE.

  Patient problems: Insufficient Information

  MAUDE report 15418261 ↗
• InjuryOct 5, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  HIP REVISION SIZE 44 PINNACLE MULTI HOLE CUP WITH LINER DISASSOCIATION. DOI: UNKNOWN, DOR: (B)(6) 2021, UNKNOWN SIDE.

  Patient problems: Foreign Body Reaction

  MAUDE report 12577722 ↗
• InjuryJul 27, 2021Naturally Worn; Noise, Audible; Naturally Worn; Noise, Audible

  COMPLAINT DESCRIPTION: PATIENT WAS REVISED TO ADDRESS LINER DISASSOCIATION. UPDATE REC'D 10/12/2015 - THE PATIENT'S MEDICAL RECORDS WERE RECEIVED. MEDICAL RECORDS WERE REVIEWED FOR MDR REPORTABILITY. ACCORDING TO THE MEDICAL RECORDS, THE PATIENT WAS REVISED TO ADDRESS PAIN. UPON REVISION THE PATIENT WAS FOUND TO HAVE METALLOSIS IN THE HIP AND A DAMAGED LINER FROM IMPINGEMENT. AT THIS TIME THERE IS NO NEW INFORMATION THAT WOULD CHANGE THE EXISTING MDR DECISION. THE COMPLAINT WAS UPDATED ON: 11/09/2015. UPDATE REC'D 8/1/2016- LEGAL CLAIM RECEIVED. THERE IS NO NEW ADDITIONAL INFORMATION THAT WOULD AFFECT THE EXISTING MDR DECISION. UPDATE REC'D 9/1/2016- LEGAL CLAIM RECEIVED. THERE IS NO NEW ADDITIONAL INFORMATION THAT WOULD AFFECT THE EXISTING MDR DECISION. COMPLAINT WAS UPDATED 09/21/2016. UPDATE APR 19, 2018: LITIGATION RECORDS RECEIVED. LITIGATION ALLEGES MENTAL AND PHYSICAL PAIN AND SQUEAKING IN THE HIP DURING POST-OPERATIVE VISIT. PATIENT UNDERWENT A REVISION OF THE ACETABULAR COMPONENT OF THE RIGHT TOTAL HIP PROSTHESIS DUE TO MECHANICAL COMPLICATIONS. SIGNIFICANT SURGICAL FINDINGS INCLUDED METALLOSIS WITH DARK TITANIUM STAINING OF THE JOINT SPACE, DISSOCIATION OF THE ACETABULAR

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Foreign Body Reaction; Pain

  MAUDE report 12235125 ↗
• InjuryJun 14, 2021Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT THA FOR OA. AFTER SURGERY, REVISION SURGERY WAS PERFORMED FOR CUP LOOSENING ON (B)(6) 2021 (CEMENTLESS CAP, ETC. WAS REMOVED AND REPLACED WITH CEMENT CUP.). THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Inadequate Osseointegration

  MAUDE report 11992042 ↗
• InjuryJun 2, 2020Malposition of Device; Malposition of Device

  IT WAS REPORTED THAT THE PATIENT HAD ANTERIOR HIP LAST FALL AND HAD DONE WELL UNTIL ABOUT A MONTH AGO, BUT HAD DISLOCATED 2 TIMES. THE PATIENT BROUGHT TO OR FOR CUP REVISION AS IT APPEARED VIA SERIAL RADIOGRAPH THAT THE CUP HAD MOVED AT SOME POINT AND HAD INCREASED ANTEVERSION ALLOWING ANTERIOR DISLOCATION. CUP APPEARED TO HAVE APPROXIMATELY 30 DEGREES OF ANTEVERSION. SURGEON REMOVED CUP AND REPLACED WITH A DUAL MOBILITY SHELL. DOI: (B)(6) 2019. DOR: (B)(6) 2020. AFFECTED SIDE: RIGHT HIP.

  Patient problems: No Code Available

  MAUDE report 10112329 ↗
• InjuryMar 5, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION TOTAL HIP REPLACEMENT; REASON FOR REVISION; PAIN AND DISCOMFORT, DIAGNOSED AS A FEMORAL NERVE PALSY. PATIENT COMPLAINING OF PAIN AND DISCOMFORT. SYMPTOMS CONSISTENT WITH FEMORAL NERVE PALSY. INVESTIGATIONS (MRI) AND SECOND OPINION CONSULTED. RADIOLOGIST OPINION AND VARIOUS ORTHOPAEDIC OPINION SUGGEST AN ACETABULAR CANCELLOUS BONE SCREW DESPITE BEING ONLY 25MM LONG MAY HAVE PERFORATED THE BONEY PELVIC WALL AND CAUSED IRRITATION OF THE FEMORAL NERVE. THIS WAS PURELY A SUSPICION BASED ON COLLECTIVE OPINION AS A POTENTIAL POSSIBLE CAUSE. THE PATIENT IS VERY SMALL IN STATURE AND HAS DYSPLASIA OF THE HIP. (ACETABULAR COMPONENT ONLY 44MM). THE PATIENT'S HIP WHEN REDUCED RESULTED IN A LEG LENGTHENING OF OVER ONE CM TO CORRECT THE SHORTENING OF THE AFFECTED LEG ASSOCIATED WITH THE DYSPLASIA OF THE HIP. THE POLYETHYLENE LINER WAS REMOVED AND THE SCREW REMOVED WITHOUT INCIDENT. THE LINER WAS THEN REPLACED WITH AN IDENTICAL NEW 28MM NEUTRAL 44MM POLYETHYLENE PINNACLE ACETABULAR LINER. THE CERAMIC FEMORAL HEAD REMAINED INSITU ON THE CORAIL FEMORAL STEM DURING THE LINER REMOVAL, SCREW REMOVAL, AND LINER REPLACEMENT. THE HIP WAS THEN REDUCED AND CLINICAL STABILITY WAS ACHIEVED WITH A RAN

  Patient problems: Discomfort; No Code Available; Pain; Tissue Damage

  MAUDE report 9793671 ↗
• InjuryApr 1, 2019Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT IT WAS CONFIRMED DISLOCATION OCCURRED ON (B)(6) 2019 BY THE X-RAY EVEN THOUGH THERE HAD BEEN NO PARTICULAR PROBLEM WITH THE CONDITION AFTER THA SURGERY PERFORMED ON (B)(6) 2019. IT WAS REPORTED THE THA SURGERY WAS PERFORMED AS FOLLOWS. THE CUP 44MM WAS FIXED WITH 3 SCREWS AFTER IT WAS CONFIRMED THE FIXATION ANGLE BY THE X-RAY. THE SURGEON TRIAL TESTED WITH TRIAL IMPLANTS EXCEPT THE CUP, CONFIRMED DISLOCATION POSITION AND LEG-LENGTH, AND EXPLANTED THE TRIAL IMPLANTS. THE LINER (+4 MM,10 DEGREE, 28MM INNER DIAMETER)WAS IMPLANTED AFTER WASHING OUT. IT WAS PLANNED TO USE THE C STEM #2 HOWEVER IT WAS NOT ABLE TO IMPLANT TO THE FEMUR SO THE CPT STEM (SIZE0 EXTENDED OFFSET/MANUFACTURED BY ZIMMER) WAS IMPLANTED AND FIXED BY THE VACU-MIX CEMENT. THE SURGEON TRIAL TESTED WITH THE TRIAL HEAD, DECIDED THE HEAD LENGTH. THE DELTA HEAD (28MM,+3.5MM/ MANUFACTURED BY ZIMMER) WAS FIXED AND THE SURGEON CONFIRMED DISLOCATION POSITION AND LEG-LENGTH. THE FIXATION ANGLE OF THE CUP WAS SLIGHTLY SHIFTED IN COMPARISON WITH THE PREOPERATIVE PLAN, BUT THE SURGERY WAS COMPLETED WITHOUT ANY PROBLEM AND THERE WAS NO SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Code Available

  MAUDE report 8471276 ↗
• InjurySep 24, 2018Malposition of Device; Malposition of Device

  IT WAS REPORTED THAT THE PATIENT'S LEFT HIP WAS REVISED DUE TO MALPOSITIONING OF THE ACETABULAR COMPONENTS.

  Patient problems: No Code Available

  MAUDE report 7903563 ↗
• InjuryFeb 26, 2018Disassembly; Device Dislodged or Dislocated; Disassembly; Device Dislodged or Dislocated

  DR (B)(6) HOSPITAL. PRIMARY: (B)(6) 2015. REVISION TO BE SCHEDULED. X-RAY IMAGES INDICATE DISASSOCIATION.

  Patient problems: Joint Disorder; No Consequences Or Impact To Patient

  MAUDE report 7295689 ↗
• InjurySep 22, 2017Malposition of Device; Malposition of Device

  THE PATIENT WAS REVISED TO ADDRESS DISLOCATION.

  Patient problems: Joint Dislocation

  MAUDE report 6886856 ↗