BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PINNACLE 100 HA ACET CUP 48MM

    MDR report key: 17957760 · Received October 18, 2023

    Report

    Report Number
    1818910-2023-21285
    Event Type
    Injury
    Date Received
    October 18, 2023
    Date of Event
    October 3, 2023
    Report Date
    October 18, 2023
    Manufacturer
    DEPUY IRELAND - 9616671
    Product Code
    LPH
    UDI-DI
    10603295009047
    PMA / PMN Number
    K192919
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY : CUP REVISION FOR PAIN AND SQUEAKING OF IMPLANT. ON X RAY, CUP APPEARS OPEN AND TOO ANTEVERTED. FOR OPEN ASSESSMENT OF CUP AND LINER. INTRAOPERATIVELY THE LINER WAS FOUND TO HAVE COMPLETELY MALFORMED AND CERAMIC HEAD HAS BEEN RUBBING AGAINST METAL SHELL. THE PRODUCT WAS NOT RETURNED TO DEPUY SYNTHES, HOWEVER PHOTOS WERE PROVIDED FOR REVIEW. REVIEW OF THE PHOTOGRAPHIC AND X-RAYS EVIDENCE CONFIRM THE REPORTED ALLEGATION. BASED ON THE POSITION OF THE FEMORAL HEAD REGARDING THE ACETABULAR CUP AND THE OBSERVATIONS OF THE INVOLVED LINER AND CERAMIC HEAD, A DISASSOCIATION EVENT BETWEEN THE LINER AND CUP WAS ABLE TO BE CONFIRMED. ADDITIONALLY, NOISE WOULD BE PRESENT DUE TO THE CERAMIC HEAD ARTICULATING AGAINST THE METAL CUP AND HE IMPLANT IS NOT IN THE PROPER POSITION. ALSO DURING THE IMAGE REVIEW IT APPEARS THAT THE ACETABULAR CUP IS POSITIONED WITH MORE ANTEVERSION ANGLE THAN IS RECOMMENDED BY DEPUY. THE OVERALL COMPLAINT WAS CONFIRMED AS THE OBSERVED CONDITION OF THE UNK HIP ACETABULAR CUP WOULD CONTRIBUTE TO THE COMPLAINED DEVICE ISSUE. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. THERE IS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE HAS CAUSED THE REPORTED COMPLAINT CONDITION. AS PART OF DEPUY SYNTHES QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST-MARKET SAFETY SURVEILLANCE ACTIVITIES. DEVICE HISTORY LOT : DHR REVIEW WAS PERFORMED ACCORDING TO "C00226 (002)" ATTACHED ON NOTES & ATTACHMENTS. PRODUCT DESCRIPTION: ALTRX NEUT 32IDX48OD. PRODUCT CODE: 122132048. LOT NUMBER: C00226. 1) QUANTITY MANUFACTURED: (B)(4). 2) DATE OF MANUFACTURE: 10/24/2016. 3) ANY ANOMALIES OR DEVIATIONS IDENTIFIED IN DHR: 0 NON-CONFORMANCES ASSOCIATED WITH THIS LOT. 4) EXPIRY DATE: 09/30/2021. 5) IFU REFERENCE: (B)(4).

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). D4: THE DEVICE CATALOG NUMBER IS UNKNOWN; THEREFORE, UDI IS UNAVAILABLE. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803 (AND/OR PART 4, AS APPLICABLE). THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY DEPUY SYNTHES, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY DEPUY SYNTHES JOINT RECONSTRUCTION, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, DEPUY SYNTHES JOINT RECONSTRUCTION, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY DEPUY SYNTHES JOINT RECONSTRUCTION, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, DEPUY SYNTHES JOINT RECONSTRUCTION, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. H10 ADDITIONAL NARRATIVE: IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 0

    CUP REVISION FOR PAIN AND SQUEAKING OF IMPLANT. ON X RAY, CUP APPEARS OPEN AND TOO ANTEVERTED. FOR OPEN ASSESSMENT OF CUP AND LINER. INTRAOPERATIVELY THE LINER WAS FOUND TO HAVE COMPLETELY MALFORMED AND CERAMIC HEAD HAS BEEN RUBBING AGAINST METAL SHELL. SHELL LEFT IN SITU DUE TO PATIENTS AGE AND BMI AND BONE LOSS - +4 10 DEGREE FACE CHANGING LINER INSERTED WITH 32 +1 REVISION HEAD. DOI: (B)(6) 2017. DOE: (B)(6) 2023. AFFECTED SIDE.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION WAS RECEIVED AND STATED THAT THE CUP IS UNAVAILABLE AS IT WAS LEFT IN SITU BUT THERE WAS A QUERY WITH IT HAVING BEING IMPLANTED WITH BEING TO OPEN OR THAT IT HAD MOVED, BUT IT WAS WELL FIXED ON OPENING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    242022 PINNACLE 100 HA ACET CUP 48MM HIP ACETABULAR CUP LPH DEPUY IRELAND - 9616671 727500 10603295009047

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention ALTRX NEUT 32IDX48OD| APEX HOLE ELIM POSITIVE STOP| DELTA CER HEAD 12/14 32MM +1