BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PINNACLE SECTOR II CUP 52MM

    MDR report key: 2071554 · Received April 15, 2011

    Report

    Report Number
    1818910-2011-06410
    Event Type
    Injury
    Date Received
    April 15, 2011
    Date of Event
    March 16, 2011
    Report Date
    March 16, 2011
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    KWA
    PMA / PMN Number
    K073504
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.

    Additional Manufacturer Narrative · 1

    EXAMINATION OF THE RETURNED DEVICES FINDS NOTHING OUTWARD TO INDICATE PRODUCT ERROR. REVIEW OF THE DEVICE HISTORY RECORDS DID NOT REVEAL ANY RELATED MANUFACTURING DEVIATIONS OR ANOMALIES. THERE IS EVIDENCE TO INDICATE THE ACETABULAR CUP WAS POSITIONED MORE VERTICALLY THAN RECOMMENDED BY SURGICAL TECHNIQUE. THIS CAN CONTRIBUTE TO EDGE LOADING, WHICH ADVERSELY AFFECTS LOADING OF THE BEARING AND ALSO INCREASED WEAR RATES. THE LINER EXAMINATION DOES FIND EVIDENCE OF EDGE LOADING BY THE FEMORAL HEAD AND PATIENT BODY WEIGHT. LESS THAN OPTIMUM ACETABULAR CUP PLACEMENT IS SUSPECTED TO HAVE BEEN A CONTRIBUTING FACTOR. PATIENT X-RAYS WERE REQUESTED BUT NONE RECEIVED. BASED ON THE INABILITY TO DETERMINE A ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION WAS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE PRODUCT OR ADDITIONAL INFORMATION BE RECEIVED TO CHANGE THE OUTCOME OF THE PERFORMED INVESTIGATION, THE COMPLAINT WILL BE RE-OPENED.

    Additional Manufacturer Narrative · 1

    UPDATE: (B)(4) 2012 - LITIGATION PAPERS WERE RECEIVED. EXAMINATION OF THE RETURNED DEVICES FINDS NOTHING OUTWARD TO INDICATE PRODUCT ERROR. REVIEW OF THE DEVICE HISTORY RECORDS DID NOT REVEAL ANY RELATED MANUFACTURING DEVIATIONS OR ANOMALIES. THERE IS EVIDENCE TO INDICATE THE ACETABULAR CUP WAS POSITIONED MORE VERTICALLY THAN RECOMMENDED BY SURGICAL TECHNIQUE. THIS CAN CONTRIBUTE TO EDGE LOADING, WHICH ADVERSELY AFFECTS LOADING OF THE BEARING AND ALSO INCREASED WEAR RATES. THE LINER EXAMINATION DOES FIND EVIDENCE OF EDGE LOADING BY THE FEMORAL HEAD AND PATIENT BODY WEIGHT. LESS THAN OPTIMUM ACETABULAR CUP PLACEMENT IS SUSPECTED TO HAVE BEEN A CONTRIBUTING FACTOR. PATIENT X-RAYS WERE REQUESTED BUT NONE RECEIVED. BASED ON THE INABILITY TO DETERMINE A ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION WAS NOT INDICATED. UPDATE: (B)(4) 2012 - LITIGATION PAPERS WERE RECEIVED. UPDATE: (B)(4) 2012 - MEDICAL RECORDS WERE RECEIVED. THERE IS NO NEW INFORMATION THAT WOULD CHANGE THE OUTCOME OF THE EXISTING MDR DECISION. RECORDS ARE AVAILABLE ON EXTERNAL HARD DRIVE IF NEEDED FOR FURTHER REVIEW. THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. A SEARCH OF THE COMPLAINT DATABASE FOUND NO ADDITIONAL REPORTS FOR THE REPORTED PART AND LOT CODE COMBINATIONS. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY PRODUCT CONTRIBUTION TO THE REPORTED EVENT WITH THE INFORMATION PROVIDED. BASED ON THE INABILITY TO IDENTIFY A ROOT CAUSE CORRECTIVE ACTION WAS NOT ESTABLISHED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ANY ADDITIONAL INFORMATION BE RECEIVED TO CHANGE THE OUTCOME OF THE PERFORMED INVESTIGATION, THE COMPLAINT WILL BE RE-OPENED.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY: NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. 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. DEPUY CONSIDERS THE INVESTIGATION CLOSED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY. IN ORDER TO DETERMINE IF A LOT RELATED ISSUE WAS POSSIBLE, A WORLDWIDE COMPLAINT DATABASE SEARCH WAS PERFORMED. A WORLDWIDE COMPLAINT DATABASE SEARCH FOUND NO ADDITIONAL RELATED REPORTS AGAINST THE PROVIDED PRODUCT CODE/LOT CODE COMBINATION. BASED ON THE INABILITY TO FIND ANY ADDITIONAL RELATED REPORTS AGAINST THE PROVIDED PRODUCT CODE/LOT CODE COMBINATION IT IS REASONABLE TO CONCLUDE THAT THERE ARE NO ANOMALIES WITH REGARD TO MANUFACTURING OR INSPECTION CONTAINED IN THE DEVICE HISTORY RECORDS THAT WOULD CONTRIBUTE TO THE REPORTED EVENT. PER (B)(4) A MEDICAL RECORD REVIEW IS NOT REQUIRED FOR THIS COMPLAINT RECORD. INVESTIGATIONAL INPUTS WERE REQUESTED AS INDICATED PER INTERNAL PROCEDURES FOR THIS FAILURE MODE. THE COMPLAINT INFORMATION PROVIDED HAS BEEN REVIEWED FOR COMPLAINT CODING, MEDICAL DEVICE REPORTING, AND OTHER DATA REQUIRED BY THE COMPLAINT SYSTEM. FOLLOW-UP FOR ADDITIONAL EVENT INFORMATION, IF APPLICABLE, WAS CONDUCTED UTILIZING WORK INSTRUCTION WI-7915 APPENDIX A. WITHOUT THE PHYSICAL COMPLAINT SAMPLE(S) ASSOCIATED WITH THIS REPORT, IT WAS NOT POSSIBLE TO DETERMINE IF THE DEVICE(S) FAILED TO MEET SPECIFICATION(S) AT THE TIME IT WAS RELEASED FOR DISTRIBUTION. THE DEVICE(S) ASSOCIATED WITH THIS EVENT WERE USED IN THE TREATMENT OF THE PATIENT AS PRESCRIBED BY THE PRESIDING SURGEON. FROM THE EVENT INFORMATION RECEIVED, IT WAS NOT POSSIBLE TO DETERMINE THE RELATIONSHIP OF THE DEVICE TO THE REPORTED EVENT. NO INFORMATION RECEIVED WITH THIS INDIVIDUAL COMPLAINT INDICATED THAT A BROADER INVESTIGATION OR CORRECTIVE ACTION WAS NECESSARY. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY: NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. 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. DEPUY CONSIDERS THE INVESTIGATION CLOSED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY. 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

    PT WAS REVISED TO ADDRESS SQUEAKING, ELEVATED ION LEVELS, A LARGE AMOUNT OF METALLOSIS, METAL WEAR OF THE LINER, AND MALPOSITIONING OF THE CUP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PINNACLE SECTOR II CUP 52MM 87LPH KWA DEPUY ORTHOPAEDICS INC US NA AD5E41000

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention