BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SZ 32 MM PINNACLE ALTRX POLYETHYLENE ACETABULAR

    MDR report key: 2176901 · Received July 19, 2011

    Report

    Report Number
    2176901
    Event Type
    Injury
    Date Received
    July 19, 2011
    Date of Event
    May 3, 2011
    Report Date
    July 14, 2011
    Manufacturer
    JNJ DEPUY ORTHOPEDICS
    Product Code
    LPH
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT WITH HISTORY OF DEGENERATIVE ARTHRITIS REQUIRING A RIGHT HIP REPLACEMENT. INITIAL SURGERY ON (B)(6) 2011 WAS A RIGHT TOTAL HIP REPLACEMENT USING AN S-ROM SYSTEM WITH A 15 X 20 STEM LONG NECK OFFSET WITH A 32 BEARING HEAD, COBALT CHROME +3 AND A 54 CUP WITH A POLYETHYLENE 32 MM BEARING SURFACE PUT IN THE 9 O'CLOCK POSITION. INITIAL POST OPERATIVE X-RAY, AND FOLLOW UP X-RAYS SHOW GOOD POSITION. ON (B)(6) 2011, PT COMPLAINS OF PAIN IN GROIN. PT STATES THAT HE NOTICED A "NOISE" IN THE JOINT AND FELT A POP. HE COULDN'T PUT MUCH WEIGHT ON IT. X-RAY TAKEN WAS SHOWING THAT THE POLYETHYLENE IS EITHER SPLIT AND WORN OR SPLIT OR DISLODGED ITSELF FROM ITS FIXATION AND SPUN. ON (B)(6) 2011, PT WAS RETURNED TO OPERATING ROOM FOR REVISION OF POLYETHYLENE AND FEMORAL HEAD TO RIGHT TOTAL HIP REPLACEMENT. FINDING DURING THE PROCEDURE SHOWED DISASSOCIATION POLYETHYLENE LINER, WITH EVIDENCE THAT THE LOCKING TINES HAD FAILED IN 3 LOCATIONS, AND THE HEAD WAS SCRATCHED ON THE BEARING SURFACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SZ 32 MM PINNACLE ALTRX POLYETHYLENE ACETABULAR HIP IMPLANT (IMPLANT ON THE FLY) LPH JNJ DEPUY ORTHOPEDICS 1221-32-254 FB3A71
    2 SLSZ 32 MM PINNACLE ALTRX POLYETHYLENE ACETABULAR HIP IMPLANT (IMPLANT ON THE FLY) KWA JNJ DEPUY ORTHOPEDICS FC1FG1

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention FEMORAL STEM, MANUFACTURER: JNJ DEPUY ORTHOPEDICS| IMPLANT NAME: SZ +3 S-ROM, MANUFACTURER:| INVENTORY ITEM: IMPLANT ON THE FLY ,| IMPLANT NAME: SZ 20 F XXL S-ROM PROXIMAL SLEEVE| SZ 20X15 X 165, 36 STD NECK +8 LATERAL S-ROM| SCREW CANC PINNACLE 6.5X25MM,| MODEL/CAT NO.: 121725500| SCREW CANC PINNACLE 6.5X20MM - (B)(4)| JNJ DEPUY ORTH, LOT NO: D00447427| MODEL/CAT NO.: 121720500| LOG250614, MANUFACTURER: JNJ DEPUY ORTHOPEDICS,| INVENTORY ITEM: IMPLANT ON THE FLY ,| SERIAL NO.: MODEL/CAT NO.: (B)(4),| INVENTORY ITEM: IMPLANT ON THE FLY,| INVENTORY ITEM: IMPLANT ON THE FLY ,| LOT NO.: 3193894| SERIAL NO.: MODEL/CAT NO.: (B)(4), IMPLANT NAME:| SERIAL NO.: MODEL/CAT NO.: (B)(4),| SCREW CANC PINNACLE 6.5X20MM,| SERIAL NO.: MODEL/CAT NO.: (B)(4),| LOT NO.: D00447427| JNJ DEPUY ORTHOPEDIC LOT NO.: 319786| IMPLANT NAME: SCREW CANC PINNACLE 6.5X20MM -| MANUFACTURER: JNJ DEPUY ORTHOPEDICS,