BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALTRX LIP LNR 32IDX52OD

    MDR report key: 12569503 · Received October 4, 2021

    Report

    Report Number
    1818910-2021-21822
    Event Type
    Injury
    Date Received
    October 4, 2021
    Date of Event
    September 20, 2021
    Report Date
    September 20, 2021
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    LPH
    UDI-DI
    10603295016199
    PMA / PMN Number
    K072963
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY : NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. A WORLDWIDE LOT SPECIFIC COMPLAINT DATABASE SEARCH, OR DEVICE HISTORY RECORD (DHR) REVIEW, WAS NOT POSSIBLE BECAUSE THE REQUIRED LOT NUMBER WAS NOT PROVIDED. BASED ON PREVIOUS INVESTIGATIONS, THIS COMPLICATION OF JOINT REPLACEMENT IS UNLIKELY TO HAVE BEEN THE RESULT OF A DEVICE FAILING TO MEET REQUIRED SPECIFICATIONS. THE INFORMATION RECEIVED WILL BE RETAINED FOR POTENTIAL SERIES INVESTIGATIONS IF TRIGGERED BY TREND ANALYSIS, POST MARKET SURVEILLANCE, OR OTHER EVENTS WITHIN THE QUALITY SYSTEM. DEVICE HISTORY LOT : A WORLDWIDE LOT SPECIFIC COMPLAINT DATABASE SEARCH, OR DEVICE HISTORY RECORD (DHR) REVIEW, WAS NOT POSSIBLE BECAUSE THE REQUIRED LOT NUMBER WAS NOT PROVIDED.

    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: ADDED: B5. 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). INVESTIGATION SUMMARY : UPDATE 29-NOV-2021: THE INVESTIGATION WAS RE-OPENED UPON RECEIPT OF ADDITIONAL INFORMATION. NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. A WORLDWIDE COMPLAINT DATABASE SEARCH FOUND NO OTHER RELATED REPORTED INCIDENTS AGAINST THE PROVIDED PRODUCT CODE/LOT NUMBER COMBINATION SINCE RELEASE FOR DISTRIBUTION. BASED ON PREVIOUS INVESTIGATIONS, THIS COMPLICATION OF JOINT REPLACEMENT IS UNLIKELY TO HAVE BEEN THE RESULT OF A DEVICE FAILING TO MEET REQUIRED SPECIFICATIONS. THE INFORMATION RECEIVED WILL BE RETAINED FOR POTENTIAL SERIES INVESTIGATIONS IF TRIGGERED BY TREND ANALYSIS, POST MARKET SURVEILLANCE, OR OTHER EVENTS WITHIN THE QUALITY SYSTEM. DEVICE HISTORY LOT : THE PRODUCT INVESTIGATION FOUND NO EVIDENCE SUSPECTING AN ERROR IN THE MANUFACTURING OR MATERIAL THAT WOULD BE A CONTRIBUTING FACTOR IN THE REPORTED ALLEGATION(S). WHERE THE LOT CODE WAS PROVIDED, A MANUFACTURING RECORDS EVALUATION (MRE) WAS NOT PERFORMED.

    Description of Event or Problem · 0

    1. PLEASE PROVIDE PART AND LOT OF THE LINER. 122132252 LOT J8846U ALTRX LIPPED 32X52 AND 136532710 LOT 9191953 DLT TS CERAMIC HEAD. 2. AFFECTED SIDE INVOLVED. RIGHT. 3. PLEASE CONFIRM THE YEAR OF THE PREVIOUS REVISION. WAS IT (B)(6) 2021? YES IT WAS (B)(6) 2021 (B)(6) 2021). 4. DATE OF REVISION? (B)(6) 2021.

    Description of Event or Problem · 0

    A. PLEASE PROVIDE THE LOT NUMBER OF THE ALTRX LIP LNR 32IDX52OD. - NA. B. PLEASE CONFIRM IF THERE WERE ANY DEPUY PRODUCTS INVOLVED IN THE PREVIOUS REVISION (SEP 13) DUE TO INFECTION? IF YES, PLEASE PROVIDE PRODUCT AND LOT DETAILS. OR IF THIS WAS PREVIOUSLY REPORTED, PLEASE PROVIDE THE COMPLAINT NUMBER? YES BUT I WASN¿T PRESENT. C. WAS THERE ANY SUGGESTION BY ANYONE INDICATING THAT THERE WAS OR MAY BE DEFICIENCY WITH THE PRODUCT(S)? IF YES, PLEASE PROVIDE DETAILS. NO. D. AFFECTED SIDE INVOLVED - NA.

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    REVISION AND WASHOUT OF POLY EXCHANGE AND HEAD REMOVAL DUE TO INFECTION. PREVIOUS WASHOUT AND EXCHANGE WAS DONE ON (B)(6) AT (B)(6) BY THE SURGEON. MULTIPLE SPECIMENS TAKEN DURING PROCEDURE. DOI: UNKNOWN; DOR: (B)(6) 2021; UNKNOWN SIDE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1467144 ALTRX LIP LNR 32IDX52OD PINNACLE HIP SYSTEM : HIP POLY ACETABULAR LINERS LPH DEPUY ORTHOPAEDICS INC US 1221-32-252 J8846U 10603295016199

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention ALTRX LIP LNR 32IDX52OD| DLT TS CER HD 12/14 32MM +1| ALTRX LIP LNR 32IDX52OD| DLT TS CER HD 12/14 32MM +1