BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PINN CAN BONE SCREW 6.5MMX15MM

    MDR report key: 4112814 · Received September 24, 2014

    Report

    Report Number
    1818910-2014-28742
    Event Type
    Injury
    Date Received
    September 24, 2014
    Date of Event
    September 21, 2014
    Report Date
    September 21, 2014
    Manufacturer
    JOHNSON & JOHNSON MEDICAL (SUZHOU) LTD. 3006356043
    Product Code
    NDJ
    PMA / PMN Number
    PK983014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEPUY SYNTHES HAS BEEN INFORMED THAT THE CATALOG NUMBER AND LOT NUMBER AND THIS INFORMATION IS NOT AVAILABLE. THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED. 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

    ADDITIONAL NARRATIVE: 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

    THE INVESTIGATION HAS BEEN REOPENED DUE TO RECEIVING NEW INFORMATION. DEPUY WILL NOTIFY THE FDA WHEN THE INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    EXAMINATION OF THE RETURNED 1219-28-048 PINNACLE LINER LOT E91JS1 FINDS A MATERIAL FRACTURE HAS OCCURRED NEAR THE RIM OF THE LINER AND APPROXIMATELY ONE THIRD OF THE CIRCUMFERENCE. THE EVIDENCE INDICATES THAT POST FRACTURE OF THE RIM THE LINER THEN DISASSOCIATED FROM THE ACETABULAR CUP. BECAUSE OF THE DAMAGE TO THE LINER FROM THE FRACTURE AND DISASSOCIATION IT IS NOT POSSIBLE TO CONCLUSIVELY DETERMINE IF THE LINER AND CUP LOCKING MECHANISMS WAS PROPERLY AND FULLY ENGAGED. THE POLYETHYLENE MATERIAL IS WELL BURNISHED IN THE AREA OF FRACTURE AND IMMEDIATELY BELOW. THIS WOULD BE FROM ARTICULATION OF THE FEMORAL HEAD AGAINST THE LINER WHILE IMPLANTED. THE AREA OF WEAR IS MUCH CLOSER THE RIM AND FRACTURE AREA. OPPOSITE THIS AREA AND CONTINUING DOWN NEARLY FULLY INTO THE CENTER OF THE INNER RADIUS, EVEN AFTER APPROXIMATELY THREE YEARS IMPLANTED, MACHINING LINES ARE STILL VISIBLE CONFIRMING THAT THE LINER WAS NOT CENTRALLY LOADED BY THE FEMORAL HEAD AND PATIENT BODY WEIGHT. IT HAS BEEN CONFIRMED THROUGH X-RAY REVIEW THAT THE ACETABULAR CUP WAS POSITIONED MORE VERTICALLY THAN RECOMMENDED BY SURGICAL TECHNIQUE CONTRIBUTING TO EDGE LOADING OF THE LINER. MALPOSITIONING CAN ADVERSELY AFFECT LOADING OF THE BEARING AND INCREASES PRESSURES PLACED ON THE MATERIAL. THE INVESTIGATION CAN DRAW NO FURTHER CONCLUSIONS WITH THE INFORMATION PROVIDED. BASED ON THE INABILITY TO DETERMINE ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION HAS NOT BEEN INDICATED. DEPUY STILL 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.

    Additional Manufacturer Narrative · 1

    EXAMINATION OF THE RETURNED (B)(4) PINNACLE LINER LOT E91JS1 FINDS A MATERIAL FRACTURE HAS OCCURRED NEAR THE RIM OF THE LINER AND APPROXIMATELY ONE THIRD OF THE CIRCUMFERENCE. THE EVIDENCE INDICATES THAT POST FRACTURE OF THE RIM THE LINER THEN DISASSOCIATED FROM THE ACETABULAR CUP. BECAUSE OF THE DAMAGE TO THE LINER FROM THE FRACTURE AND DISASSOCIATION IT IS NOT POSSIBLE TO CONCLUSIVELY DETERMINE IF THE LINER AND CUP LOCKING MECHANISMS WAS PROPERLY AND FULLY ENGAGED. THE POLYETHYLENE MATERIAL IS WELL BURNISHED IN THE AREA OF FRACTURE AND IMMEDIATELY BELOW. THIS WOULD BE FROM ARTICULATION OF THE FEMORAL HEAD AGAINST THE LINER WHILE IMPLANTED. THE AREA OF WEAR IS MUCH CLOSER THE RIM AND FRACTURE AREA. OPPOSITE THIS AREA AND CONTINUING DOWN NEARLY FULLY INTO THE CENTER OF THE INNER RADIUS, EVEN AFTER APPROXIMATELY THREE YEARS IMPLANTED, MACHINING LINES ARE STILL VISIBLE CONFIRMING THAT THE LINER WAS NOT CENTRALLY LOADED BY THE FEMORAL HEAD AND PATIENT BODY WEIGHT. IT HAS BEEN CONFIRMED THROUGH X-RAY REVIEW THAT THE ACETABULAR CUP WAS POSITIONED MORE VERTICALLY THAN RECOMMENDED BY SURGICAL TECHNIQUE CONTRIBUTING TO EDGE LOADING OF THE LINER. MALPOSITIONING CAN ADVERSELY AFFECT LOADING OF THE BEARING AND INCREASES PRESSURES PLACED ON THE MATERIAL. THE INVESTIGATION CAN DRAW NO FURTHER CONCLUSIONS WITH THE INFORMATION PROVIDED. BASED ON THE INABILITY TO DETERMINE ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION HAS NOT BEEN INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY.

    Additional Manufacturer Narrative · 1

    POLY DAMAGED IN PINNACLE SOCKET ? DISLOCATED HIP (B)(6) HAS A CORAIL PINNACLE PATIENT DISLOCATED AT 3 YEARS 2 MONTHS. REVISED LAST WEEK, MARATHON POLY WAS INSITU BUT DAMAGED AROUND THE RIM INCLUDING A PIECE CHIPPED OFF, 28MM ARTICULEZE HEAD HAS DECENT EVIDENCE OF STRIPE WEAR AND DISLOCATION DAMAGE, FINALLY, ONE OF THE PINNACLE SCREWS HAD BACKED OUT. REVISED WITH CERAMIC LINER DUE TO CUP / SHELL SCRATCHING + CERAMIC TS HEAD THE REPORTED EVENT HAS BEEN EVALUATED AND WILL BE MONITORED. DEPUY 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. 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

    POLY DAMAGED IN PINNACLE SOCKET? DISLOCATED HIP. HAS A CORAIL PINNACLE PATIENT DISLOCATED AT 3 YEARS 2 MONTHS. REVISED LAST WEEK, MARATHON POLY WAS INSITU, BUT DAMAGED AROUND THE RIM INCLUDING A PIECE CHIPPED OFF, 28MM ARTICULEZE HEAD HAS DECENT EVIDENCE OF STRIPE WEAR AND DISLOCATION DAMAGE, FINALLY, ONE OF THE PINNACLE SCREWS HAD BACKED OUT. REVISED WITH CERAMIC LINER DUE TO CUP / SHELL SCRATCHING + CERAMIC TS HEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    596155 PINN CAN BONE SCREW 6.5MMX15MM HIP OTHER IMPLANT NDJ JOHNSON & JOHNSON MEDICAL (SUZHOU) LTD. 3006356043 D00448815

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Required Intervention