BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUMMIT POR TAPER SZ7 HI OFF

    MDR report key: 2800489 · Received October 22, 2012

    Report

    Report Number
    1818910-2012-76603
    Event Type
    Injury
    Date Received
    October 22, 2012
    Date of Event
    December 30, 2011
    Report Date
    August 16, 2012
    Manufacturer
    DEPUY RAYNHAM
    Product Code
    LPH
    PMA / PMN Number
    K001991
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    **UPDATE** (B)(4) 2012 - LITIGATION PAPERS ALLEGE THAT THE PATIENT HAS SUFFERED SCLEROSIS IN ACETABULUM, BONY IRRITATION AND LOOSENING; SIGNIFICANT ABDUCTOR DEFICIENCY WITH TENDINOUS INSERTION ONTO GREATER TROCHANTER; SIGNIFICANT ATROPHY OF GLUTEUS MEDIUS AND MINIMUS MUSCULATURE; FRAGMENTATION OF POSTERIOR WALL AND POSTERIOR COLUMN OF LEFT HIP; LOOSENING OF ACETABULAR COMPONENT; SCAR TISSUE FORMATION AND CAVITARY DEFECTS POSTERIOR WALL AND ILIUM; ABDUCTOR DEFICIENCY; LEG LENGTH DISCREPANCY AND IMBALANCE; LIMPING AND ALTERED GAIT, AND BACK, LEG, ANKLE AND KNEE PAIN AND INJURY; DAMAGE TO THE TISSUES AND STRUCTURE OF THE HIP; INFLAMMATORY AND LYMPHOCYTIC RESPONSE TO METAL ON METAL HIP IMPLANT; SYNOVITIS; MECHANICAL COMPLICATIONS LEFT TOTAL HIP REPLACEMENT; HYPERACTIVE SYNOVIUM; BURSAL AND JOINT SCARRING; CHROMIUM AND COBALT TOXICITY; AVASCULAR NECROSIS; PHYSICAL PAIN; DISFIGUREMENT, ANXIETY AND LOSS OF LIFES PLEASURES AS A RESULT OF THE IMPLANTATION WITH THE ASR HIP IMPLANT. DOI: (B)(6) 2009 (LEFT HIP), DOB: (B)(6) 1933, (B)(6). ADDED PRODUCTS: UNKNOWN DEPUY ASR FEMORAL HEAD, UNKNOWN DEPUY ASR ADAPTER SLEEVE, UNKNOWN DEPUY FEMORAL STEM. **UPDATE** (B)(4) 2012 - PLAINTIFF'S PRELIMINARY DISCLOSURE FORM WAS RECEIVED, WHICH IDENTIFIED PART/LOT INFORMATION. THE COMPLAINT AND ASSOCIATED MDRS WERE UPDATED. EXAMINATION OF THE REPORTED DEVICES WAS NOT POSSIBLE AS THEY WERE NOT RETURNED. A SEARCH OF THE COMPLAINTS DATABASES FINDS NO OTHER REPORTS AGAINST THE PRODUCT AND LOT CODE COMBINATIONS SINCE THEIR RELEASE TO DISTRIBUTION. THE INVESTIGATION CAN DRAW NO CONCLUSION 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 AT THIS TIME. SHOULD THE PRODUCT AND/OR ADDITIONAL INFORMATION BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED.

    Additional Manufacturer Narrative · 1

    (B)(4).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

    DEPUY STILL CONSIDERS THIS INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    PATIENT WAS REVISED TO ADDRESS ACETABULAR CUP LOOSENING. **UPDATE** (B)(4) 2012 LITIGATION PAPERS ALLEGE THAT THE PATIENT HAS SUFFERED SCLEROSIS IN ACETABULUM, BONY IRRITATION AND LOOSENING; SIGNIFICANT ABDUCTOR DEFICIENCY WITH TENDINOUS INSERTION ONTO GREATER TROCHANTER; SIGNIFICANT ATROPHY OF GLUTEUS MEDIUS AND MINIMUS MUSCULATURE; FRAGMENTATION OF POSTERIOR WALL AND POSTERIOR COLUMN OF LEFT HIP; LOOSENING OF ACETABULAR COMPONENT; SCAR TISSUE FORMATION AND CAVITARY DEFECTS POSTERIOR WALL AND ILIUM; ABDUCTOR DEFICIENCY; LEG LENGTH DISCREPANCY AND IMBALANCE; LIMPING AND ALTERED GAIT, AND BACK, LEG, ANKLE AND KNEE PAIN AND INJURY; DAMAGE TO THE TISSUES AND STRUCTURE OF THE HIP; INFLAMMATORY AND LYMPHOCYTIC RESPONSE TO METAL ON METAL HIP IMPLANT; SYNOVITIS; MECHANICAL COMPLICATIONS LEFT TOTAL HIP REPLACEMENT; HYPERACTIVE SYNOVIUM; BURSAL AND JOINT SCARRING; CHROMIUM AND COBALT TOXICITY; AVASCULAR NECROSIS;PHYSICAL PAIN; DISFIGUREMENT, ANXIETY AND LOSS OF LIFES PLEASURES AS A RESULT OF THE IMPLANTATION WITH THE ASR HIP IMPLANT. **UPDATE** (B)(4) 2012 - PLAINTIFF'S PRELIMINARY DISCLOSURE FORM WAS RECEIVED, WHICH IDENTIFIED PART/LOT INFORMATION. THE COMPLAINT AND ASSOCIATED MDRS WERE UPDATED.

    Description of Event or Problem · 1

    LITIGATION PAPERS ALLEGE THAT THE PATIENT HAS SUFFERED SCLEROSIS IN ACETABULUM, BONY IRRITATION AND LOOSENING; SIGNIFICANT ABDUCTOR DEFICIENCY WITH TENDINOUS INSERTION ONTO GREATER TROCHANTER; SIGNIFICANT ATROPHY OF GLUTEUS MEDIUS AND MINIMUS MUSCULATURE; FRAGMENTATION OF POSTERIOR WALL AND POSTERIOR COLUMN OF LEFT HIP; LOOSENING OF ACETABULAR COMPONENT; SCAR TISSUE FORMATION AND CAVITARY DEFECTS POSTERIOR WALL AND ILIUM; ABDUCTOR DEFICIENCY; LEG LENGTH DISCREPANCY AND IMBALANCE; LIMPING AND ALTERED GAIT, AND BACK, LEG, ANKLE AND KNEE PAIN AND INJURY; DAMAGE TO THE TISSUES AND STRUCTURE OF THE HIP; INFLAMMATORY AND LYMPHOCYTIC RESPONSE TO METAL ON METAL HIP IMPLANT; SYNOVITIS; MECHANICAL COMPLICATIONS LEFT TOTAL HIP REPLACEMENT; HYPERACTIVE SYNOVIUM; BURSAL AND JOINT SCARRING; CHROMIUM AND COBALT TOXICITY; AVASCULAR NECROSIS;PHYSICAL PAIN; DISFIGUREMENT, ANXIETY AND LOSS OF LIFES PLEASURES AS A RESULT OF THE IMPLANTATION WITH THE ASR HIP IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUMMIT POR TAPER SZ7 HI OFF FEMORAL STEM HIP IMPLANT LPH DEPUY RAYNHAM DP5BJ1

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention