PINNACLE 1219-32-056Recalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 10603295013921), received between Sep 22, 2017 and Mar 25, 2025 — classified as 22 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (12 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. How this data works · Data updated Oct 13, 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.

• InjuryMar 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THERE WAS A REVISION OF A C-STEM PINNACLE. THE REASON FOR REVISION WAS BECAUSE THE STEM WAS LOOSE, AND THE HIP WAS UNSTABLE. NO ALLEGATION WAS MADE BY THE SURGEON IN RELATION TO THE LOOSE STEM. THE CEMENT/STEM INTERFACE WAS LOOSE. CEMENT BONE/BONE INTERFACE WAS SOUND. THE SURGEON NOTED THAT IT WAS A VERY DIFFICULT PRIMARY. IT WAS DONE BY A DIFFERENT SURGEON AND THEY STRUGGLED TO GET A SZ 1HO C-STEM IN. THE X-RAY SHOWED THAT DUE TO THE ANTERIOR-LATERAL APPROACH, THE STEM WAS PUT IN VARUS. THE HIP WAS UNSTABLE BECAUSE AT THE PRIMARY SURGERY, THE CUP WAS PLACED AT THE WRONG VERSION. THE CUP WAS EXPLANTED. IT WAS EXTREMELY WELL FIXED. THE LINER WAS EXPLANTED WITH THE SHELL, BUT THE LOT NUMBER IS UNREADABLE AS THE LINER WAS DAMAGED WHEN EXPLANTED. RECLAIM BIMENTUM WAS IMPLANTED. AFFECTED SIDE: RIGHT SIDE.

  Patient problems: Joint Laxity

  MAUDE report 21687923 ↗
• InjuryNov 30, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ADDITIONAL INFORMATION RECEIVED STATES THAT THIS WAS A REVISION CASE DUE TO THE ISSUE WITH THE LINER, SO THE CASE TOOK 1 ½ HOURS.

  Patient problems: Foreign Body Reaction; Physical Asymmetry

  MAUDE report 18239900 ↗
• InjuryAug 15, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION OF A C-STEM PINNACLE DUE TO INFECTION. ALL COMPONENTS WERE REMOVED (STEM, HEAD, LINER, AND CUP). PRIMARY SURGERY WAS DONE (B)(6) 2019. A TWO STAGE REVISION WAS DONE WHERE THE INFECTED IMPLANTS WERE REMOVED AND THE SITE WAS THOROUGHLY CLEANED. NEW IMPLANTS WERE THEN IMPLANTED. SEE PROVIDED PHOTOS AS THE NUMBERS I TOOK PHOTOS OF FOR THE CUP AND HEAD WEREN'T ABLE TO BRING UP THE ITEMS IN THE IMPACTED PRODUCTS. THAT'S WHY THE HEAD AND CUP ARE NOT LISTED. MALE. LEFT SIDE. 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. WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: UNKNOWN. IS THE PATIENT PART OF A CLINICAL STUDY? UNKNOWN. IP-01499334 DEVICE PROPERTY OF: NONE. DEVICE IN POSSESSION OF: NONE. IP-01499335 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 IN

  Patient problems: Unspecified Infection

  MAUDE report 15225413 ↗
• InjuryJul 19, 2022Device Dislodged or Dislocated; Naturally Worn; Device Dislodged or Dislocated; Naturally Worn

  PATIENT HAS POLYETHYLENE WEAR OUTSIDE THE REGULAR STANDARDS. FIRST SURGERY PERFORMED 4 YEARS AGO SECOND SURGERY PERFORMED 2 YEARS AGO THIRD SURGERY WILL BE ON JULY 4.

  Patient problems: Insufficient Information

  MAUDE report 15051731 ↗
• InjuryJun 10, 2022Naturally Worn; Naturally Worn

  POLY WEAR WAS REPORTED. PRIMARY WAS DONE ON 2007. DOI: 2007, DOR: (B)(6) 2022, AFFECTED SIDE: UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 14653461 ↗
• InjuryJan 25, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION COMPLETED DUE TO PAIN. DOI: UNKNOWN; DOR: (B)(6) 2022; AFFECTED SIDE : RIGHT HIP.

  Patient problems: Pain

  MAUDE report 13342919 ↗
• InjuryDec 1, 2021Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE PATIENT RETURNED TO SURGERY FOR ECCENTRIC POLY WEAR. THE HEAD AND LINER WERE REPLACED WITH A 40MM HEAD AND LINERS. DOI: 15 YEARS AGO - DOR: (B)(6) 2021 (RIGHT HIP).

  Patient problems: Insufficient Information

  MAUDE report 12908986 ↗
• InjurySep 2, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ADDITIONAL INFORMATION RECEIVED INDICATED THAT THERE WAS A FEMUR FRACTURE, BUT NOT A DISLOCATION. THERE WAS ABOUT 20 MINUTES SURGICAL DELAY.

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

  MAUDE report 12413375 ↗
• InjuryJul 6, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THERE WAS A REVISION CASE INVOLVING A PINNACLE LINER. THE REVISION CASE HAPPENED (B)(6) 2021 AND IT WAS PERFORM DUE TO THE PINNACLE LINER AND THE 3 PEGS WERE FLATTENED AND DISLODGED FROM THE ARDS IN THE PINNACLE CUP. THE LINER WAS DISCARDED INTO A SHARPS BIN AND IS NOT AVAILABLE TO BE SENT FOR TESTING. THE PRIMARY CASE WAS ON THE (B)(6) 2019. FOR THE REVISION, THE PINNACLE CUP WAS LEFT IN THE PATIENT AND THE LINER WAS CHANGED.

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

  MAUDE report 12121131 ↗
• InjuryMar 30, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  POST THA THE PATIENT CAME BACK WITH A DISSOCIATED PINNACLE POLY LINER LEADING TO X-RAY AND WILL BE REVISED. THERE WAS NOT A DEPUY HEAD , THEY HAVE PUT IN A HYBRID VERSION WITH A STEM AND HEAD FROM Z/B. DUE TO THE METAL DEBRIS IN THE JOINT THE OR TIME WAS LONGER THAN EXPECTED. APPROXIMATELY 30-45 MINUTES TO CLEAN OUT THE METAL DEBRIS FROM THE TISSUES IN THE JOINT. THERE WAS A LOT OF METAL DEBRIS IN THE HIP JOINT WITCH WAS REMOVED AND A NEW ALTRX LINER WAS IMPLANTED. THE PINNACLE CUP-121731056 LOT NR 9660625 WAS A BIT WORN ON THE EDGE BUT MOSTLY THE DEBRIS CAME FROM THE METAL HEAD FROM Z/B THAT ALSO WAS EXCHANGED. THE HEAD AND STEM IS FROM Z/B. THE PATIENT IS A MALE AND THE AFFECTED SIDE IS RIGHT.

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

  MAUDE report 11590695 ↗
• MalfunctionJul 13, 2020Difficult to Insert; Difficult to Insert

  INSERT WAS TOO SMALL FOR CUP. NO FIT WHEN INSERTING. WHERE / WHEN DID THE EVENT OCCUR? INTRA-OP. WAS SURGERY TIME EXTENDED AS A DIRECT RESULT OF INCIDENT? YES, WITH APPROXIMATELY 15 MINUTES. WHAT ACTION WAS TAKEN/REQUIRED TO MANAGE THE PROBLEM DURING THE PROCEDURE? WITH SAME LIKE PRODUCT. WAS A PATIENT INVOLVED? YES.

  Patient problems: No Code Available; Not Applicable

  MAUDE report 10266363 ↗
• InjuryJan 7, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE DOCTOR HAD A MIR REQUEST: THE HIP STEM (IMPLANTED TWO DAYS BEFORE) HAS COME LOOSE FROM THE CEMENT MANTLE WHEN THE FEMORAL HEAD WAS REPLACED. PRODUCT UNKNOWN CORAIL CEMENTED HIP STEM.

  Patient problems: Joint Dislocation; No Code Available

  MAUDE report 9559252 ↗
• InjuryJul 22, 2019Device Dislodged or Dislocated; Naturally Worn; Device Dislodged or Dislocated; Naturally Worn

  IT WAS REPORTED THE PATIENT WAS REVISED DUE TO THE DISLOCATING OF THE NEUTRAL POLY AND WAS REPLACED WITH A PLUS 4 10 DEGREE. DOI: UNKNOWN; DOR: (B)(6) 2019; LEFT HIP.

  Patient problems: Joint Dislocation; No Code Available

  MAUDE report 8813301 ↗
• InjuryMay 17, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PATIENT WAS REVISED DUE TO DISLOCATION. DOI: (B)(6) 2019. DOR: (B)(6) 2019. RIGHT HIP.

  Patient problems: Joint Dislocation; No Code Available

  MAUDE report 8621336 ↗
• InjuryApr 15, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  DISASSOCIATED LINER REMOVED AND REPLACED WITH NEW 36/56 NEUTRAL LINER. CERAMIC HEAD REMOVED AND REPLACED BY DELTA TS CERAMIC 36 +5 HEAD.

  Patient problems: No Code Available

  MAUDE report 8515147 ↗
• InjuryDec 3, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION DUE TO INFECTION. DOI: UNKNOWN, DOR: (B)(6) 2018, RIGHT HIP.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 8125403 ↗
• InjurySep 13, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  INLAY DISLOCATED.

  Patient problems: Not Applicable

  MAUDE report 7872624 ↗
• InjuryMay 15, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PATIENT WAS REVISED TO ADDRESS DISLOCATION. DOI: (B)(6) 2008: DOR: (B)(6) 2018; LEFT HIP. NO SURGICAL DELAY.

  Patient problems: Joint Dislocation; Not Applicable

  MAUDE report 7513694 ↗
• InjuryDec 22, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT WAS REVISED TO ADDRESS DISLOCATION. DOI: UNKNOWN; DOR: (B)(6) 2017; RIGHT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 7142407 ↗
• InjuryNov 28, 2017Disassembly; Disassembly

  PATIENT WAS REVISED TO ADDRESS DISASSOCIATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7065876 ↗
• InjuryOct 20, 2017Disassembly; Noise, Audible; Disassembly; Noise, Audible

  IT STATES SECOND LEFT HIP REVISION. THE LINER DISPLACED FROM PINNACLE CUP AND WAS REVISED. PATIENT BENT OVER ONE DAY AND HEARD A CLICK THEN FELT PAIN. X-RAY SHOWS METAL HEAD ARTICULATING ON PINNACLE CUP. METALOSIS IS PRESENT. PATIENT UNDERWENT 1ST REVISION ON (B)(6) 2017, HEAD AND LINER REVISED DUE TO DISLODGED LINER.

  Patient problems: Foreign Body Reaction; Pain

  MAUDE report 6964721 ↗
• InjuryOct 5, 2017Disassembly; Disassembly

  THE PATIENT WAS REVISED TO ADDRESS PAIN AND SUSPECTED LINER DISASSOCIATION.

  Patient problems: Pain

  MAUDE report 6919023 ↗
• InjurySep 22, 2017Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PATIENT WAS REVISED TO ADDRESS DISLOCATION.

  Patient problems: Joint Dislocation

  MAUDE report 6886402 ↗