PINNACLE 2217-50-048Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10603295099000), received between Dec 14, 2017 and Sep 15, 2026 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Break” (3 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 15, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50775570 ↗
• MalfunctionOct 17, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT IT WAS DISCOVERED DURING THE REVIEW AFTER WASHING BUT BEFORE THE OPERATION THAT THE GASKET ON ONE OF THE INSTRUMENTS WAS IN POOR CONDITION. IT APPEARS THAT THE RUBBER ON THE INSTRUMENT HAS WORN OUT DUE TO NORMAL USE. THE ITEM WAS NOT USED IN THE SURGERY SO NO AFFECT ON A SURGERY. THE WORN-OUT ITEM HAS BEEN REMOVED FROM THE MODULE AND REPLACED WITH A NEW ONE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23328140 ↗
• MalfunctionSep 13, 2024Naturally Worn; Naturally Worn

  ADDITIONAL INFORMATION RECEIVED STATES THAT THE WELD AT THE HANDLE WAS BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20213180 ↗
• MalfunctionJun 14, 2024Break; Break

  ADDITIONAL INFORMATION WAS RECEIVED: WAS/WERE THERE ANY ADVERSE CONSEQUENCE/S THAT AFFECTED THE PATIENT BECAUSE OF THE REPORTED EVENT? NO. WAS THERE A SURGICAL DELAY? IF YES, WHAT IS THE DURATION OF THE DELAY? NO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19536472 ↗
• MalfunctionMay 13, 2020Material Twisted/Bent; Scratched Material; Material Twisted/Bent; Scratched Material

  DURING THE COVID PERIOD, HOSPITAL STAFF AT (B)(6) IN (B)(6) EXAMINED A VARIETY OF SETS AND CAME ACROSS SEVERAL DAMAGED INSTRUMENTS (7 TOTAL) IN THEIR PINNACLE BANTAM SET THAT REQUIRE REPLACING: THE PINNACLE IMPACTOR ADAPTER AND SHELL TRIAL WERE CROSS THREADED AND NO LONGER USABLE (221750048 & 221701038). THE 28MM LINER IMPACTOR WAS GAUGED (221750006). THE ARTICULEZE TRIAL BALLS AND NEUTRAL TRIAL LINERS WERE ALSO GAUGED AND NOT USABLE DUE TO WEAR AND TEAR (253070000, 253069000, 221828044 & 221828046). ALL ITEMS WERE DISCARDED. NO PATIENT OR INTRA-OP ISSUES AS THIS DID NOT OCCUR IN THE OPERATING ROOM. PLEASE SEND REPLACEMENTS TO THE FOLLOWING ADDRESS: (B)(6). PATIENT STATUS/ OUTCOME / CONSEQUENCES: NO, WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: UNKNOWN, IS THE PATIENT PART OF A CLINICAL STUDY: UNKNOWN, (B)(4), DEVICE PROPERTY OF: NONE, DEVICE IN POSSESSION OF: NONE, (B)(4), DEVICE PROPERTY OF: NONE, DEVICE IN POSSESSION OF: NONE, (B)(4), DEVICE PROPERTY OF: NONE, DEVICE IN POSSESSION OF: NONE, (B)(4), DEVICE PROPERTY OF: NONE, DEVICE IN POSSESSION OF: NONE, (B)(4), DEVICE PROPERTY OF: NONE, DEVICE IN POSSESSION OF: NONE

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10053532 ↗
• MalfunctionJan 17, 2019Entrapment of Device; Entrapment of Device

  EVENT: TOTAL HIP REPLACEMENT SURGERY WAS PERFORMED, AT THE TIME OF PLACING THE FINAL ACETABULAR CUP PINNACLE # 40, AND UNSCREWING THE ENTIRE POSITIONER OF THE CUP AFTER BEING IMPACTED ON ITS ACCEPTABILITY. THE PIECE IN QUESTION IS "STUCK IN THE CUP", THIS INCIDENT CAUSES THE SURGEON TO HAVE TO USE OTHER CLAMPS TO UNSCREW THE PIECE FROM THE CUP, RISKING THAT THE SAME CUP MOVED FROM WHERE IT SHOULD GO. FINALLY, THE PIECE IS UNSCREWED IN A SOMEWHAT ABRUPT MANNER.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8256978 ↗
• MalfunctionJan 17, 2019Entrapment of Device; Entrapment of Device

  EVENT: TOTAL HIP REPLACEMENT SURGERY WAS PERFORMED, AT THE TIME OF PLACING THE FINAL ACETABULAR CUP PINNACLE # 40, AND UNSCREWING THE ENTIRE POSITIONER OF THE CUP AFTER BEING IMPACTED ON ITS ACCEPTABILITY. THE PIECE IN QUESTION IS "STUCK IN THE CUP", THIS INCIDENT CAUSES THE SURGEON TO HAVE TO USE OTHER CLAMPS TO UNSCREW THE PIECE FROM THE CUP, RISKING THAT THE SAME CUP MOVED FROM WHERE IT SHOULD GO. FINALLY, THE PIECE IS UNSCREWED IN A SOMEWHAT ABRUPT MANNER. THE PROCEDURE IS FINISHED WITHOUT ANY OTHER INCONVENIENCE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8256955 ↗
• MalfunctionAug 6, 2018Break; Detachment of Device or Device Component; Appropriate Device Problem Term/Code Not Available; Break; Detachment of Device or Device Component; Appropriate Device Problem Term/Code Not Available

  RUBBER BUNG ON PINNACLE BANTAM CUP IMPACTOR CAME LOOSE AND FELL INTO PELVIC CREVICE INTRAOPERATIVELY. NO PATIENT COMPROMISE AS SURGEON WAS ABLE TO FISH RUBBER BUNG OUT. PATIENT CONSEQUENCE? :NO. IS THE INFORMATION BEING SUBMITTED FOR THIS COMPLAINT ALL THE DETAILS THAT ARE KNOWN/AVAILABLE REGARDING THIS EVENT? : YES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7753475 ↗
• MalfunctionDec 14, 2017Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THAT DURING SURGERY WHILE SURGEON IMPACTING THE CUP USING THE ADAPTOR (PART#: 221750048, LOT#: UNKNOWN) CONNECTED TO AN IMPACTOR (PART#: UNKNOWN), THE ADAPTOR GOT DISCONNECTED AND THEN LEFT ON THE CUP. HE REMOVED THE ADAPTOR FROM THE CUP USING A LONG NOSE PLIERS AND SO ON. DOE: (B)(6) 2017; SURGICAL DELAY: 10 MINUTES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7117497 ↗