BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PFC SIG RPF INS SZ 4 10MM

    MDR report key: 12813014 · Received November 15, 2021

    Report

    Report Number
    1818910-2021-25098
    Event Type
    Injury
    Date Received
    November 15, 2021
    Date of Event
    October 26, 2021
    Report Date
    January 18, 2022
    Manufacturer
    DEPUY INTERNATIONAL LTD - 8010379
    Product Code
    JWH
    UDI-DI
    10603295230410
    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 ==> ACCORDING TO THE INFORMATION RECEIVED ¿REVISION OF A SIGMA PFC PS RP TOTAL KNEE. REASON FOR REVISION WAS DUE TO POLY SPIN OUT. THIS OCCURRED APPROXIMATELY 1 YEAR AGO. THE PRIMARY SURGERY WAS DONE ON (B)(6) 2005.¿ THE PHYSICAL DEVICE WAS NOT RETURNED, HOWEVER PHOTOS WERE PROVIDED FOR REVIEW. THE PHOTOS PROVIDED WITH THE COMPLAINT CONSISTED OF ¿COULTER.SIGMA POLY.1.JPG¿, ¿COULTER.SIGMA POLY.2.JPG¿, ¿COULTER.SIGMA POLY.3.JPG¿ AND ¿COULTER.SIGMA POLY.4.JPG¿ OF THE DEVICE 951040 PFC SIG RPF INS SZ 4 10MM. THE PHOTOS WERE FORWARDED TO DEPUY SYNTHES MATERIAL SCIENCE FOR FURTHER EVALUATION. REVIEW OF THE PHOTOS FOUND WEAR, DELAMINATION, CRAZING, AND OTHER DAMAGE CONSISTENT WITH ~15 YEARS OF SERVICE WITH ARTICULAR WEAR AND LOADING WITHIN ANTICIPATED REGIONS OF THE INSERT. THE SUPERIOR CAM OF THE INSERT IS DAMAGED CONSISTENT WITH SPINOUT BETWEEN THE FEMORAL COMPONENT AND THE MATING ARTICULAR PORTIONS OF THE TIBIAL INSERT. WITH THE GROSS LOSS OF MATERIAL AND FRACTURE OF THE POSTERIOR ASPECT OF THE INSERT, COUPLED WITH THE DAMAGE TO THE SUPERIOR CAM, IT SEEMS LIKELY THE INSERT ROTATED 180 DEGREES WITH RESPECT TO THE FEMORAL COMPONENT (WHILE STILL RETAINED WITHIN THE CONE OF THE TIBIAL TRAY). A MANUFACTURING RECORDS EVALUATION (MRE) WAS NOT PERFORMED AS NO VALID FINISHED GOODS LOT NUMBER WAS PROVIDED FOR THIS DEVICE. BASED ON THE OBSERVATIONS OF THE GIVEN INFORMATION, IS NOT POSSIBLE TO DETERMINE A DEFINITIVE ROOT CAUSE OF THE SPINOUT. 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 SYNTHES CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY. DEVICE HISTORY LOT ==> A MANUFACTURING RECORDS EVALUATION (MRE) WAS NOT PERFORMED AS NO VALID FINISHED GOODS LOT NUMBER WAS PROVIDED FOR THIS DEVICE.

    Additional Manufacturer Narrative · 0

    (B)(4). IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH 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

    REVISION OF A SIGMA PFC PS RP TOTAL KNEE. REASON FOR REVISION WAS DUE TO POLY SPIN OUT. THIS OCCURRED APPROXIMATELY 1 YEAR AGO. THE PRIMARY SURGERY WAS DONE ON (B)(6) 2005. MALE, RIGHT SIDE. THE 10MM POLY WAS REMOVED AND WE THEN TRIALED AND IMPLANTED A 12.5MM POLY. DOI: (B)(6) 2005, DOR: APPROX. ONE YEAR AGO, RIGHT SIDE.

    Description of Event or Problem · 0

    A. PLEASE CONFIRM IF THE POST ON THE INSERT CAME OFF FROM THE TIBIAL TRAY OR DID IT JUST SPIN-OUT FOR MORE THAN 90 DEGREES? UNKNOWN. B. WAS THERE ANY ADVERSE CONSEQUENCES THAT AFFECTED THE PATIENT BECAUSE OF THE REPORTED EVENT? REVISION SURGERY REQUIRED. C. WAS THERE A SURGICAL DELAY BECAUSE OF THIS EVENT? IF YES, WHAT IS THE DURATION OF THE DELAY? NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1711652 PFC SIG RPF INS SZ 4 10MM PFC SIGMA RP-F : KNEE TIBIAL INSERT JWH DEPUY INTERNATIONAL LTD - 8010379 95-1040 10603295230410

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention PFC SIG RPF INS SZ 4 10MM