BEUDAMED
    FDA Adverse Event Injury Summary report: N

    METASUL® LDH®, HEAD ADAPTER, XL, +8, TAPER 12/14-18/20

    MDR report key: 14102591 · Received April 13, 2022

    Report

    Report Number
    0009613350-2022-00231
    Event Type
    Injury
    Date Received
    April 13, 2022
    Date of Event
    May 13, 2019
    Report Date
    May 3, 2022
    Manufacturer
    ZIMMER SWITZERLAND MANUFACTURING GMBH
    Product Code
    KWA
    PMA / PMN Number
    K053536
    Removal / Correction Number
    9613350-07/15/2008-001C
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONCOMITANT MEDICAL PRODUCT: DUROM US ACET CMPNT 54/48 N CATALOG#: 01.00214.154; LOT#: 2299090; METASUL® LDH®, HEAD, 48, CODE N, TAPER 18/20 CATALOG#: 01.00181.480 ; LOT#: 2314686; FEMORAL STEM PRESS-FIT COLLARLESS 12/14 NECK TAPER STANDARD BODY STANDARD NECK CATALOG#: 00-7864-014-00; LOT#: 80358389. DUE TO FACT THAT THIS IS A LEGAL CLAIM, OUR LEGAL DEPARTMENT HAS BEEN PROVIDED WITH THE AVAILABLE FACTS FROM THE CUSTOMER. ZIMMER (B)(4) LEGAL DEPARTMENT IS WELL TRAINED AND PASSES ALL INFORMATION CONCERNING THE CASE TO OUR COMPLAINT HANDLING DEPARTMENT. AS SOON AS SUPPLEMENTAL INFORMATION BECOMES AVAILABLE AN UPDATED REPORT WILL BE SUBMITTED. THE MANUFACTURER DID NOT RECEIVE X-RAYS, OR OTHER SOURCE DOCUMENTS FOR REVIEW. SURGICAL REPORTS WERE RECEIVED AND WILL BE REVIEWED AS PART OF ONGOING INVESTIGATION. THE MANUFACTURER DID NOT RECEIVE THE DEVICE FOR INVESTIGATION. THE LOT NUMBER OF THE DEVICE WAS RECEIVED. THE DEVICE HISTORY RECORDS WILL BE REVIEWED DURING INVESTIGATION. A CAUSE FOR THIS SPECIFIC EVENT CANNOT BE ASCERTAINED FROM THE INFORMATION PROVIDED. AS SOON AS SUPPLEMENTAL INFORMATION BECOMES AVAILABLE AN UPDATED REPORT WILL BE SUBMITTED. ZIMMER BIOMET¿S REFERENCE NUMBER OF THIS FILE IS (B)(4). THE FOLLOWING REPORTS ARE ASSOCIATED WITH THIS EVENT: 0009613350-2022-00229 AND 0009613350-2022-00230.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. EVENT DESCRIPTION: IT WAS REPORTED THAT RIGHT HIP PAINFUL HIP/FAILED ARTHROPLASTY WITH METAL ON METAL ARTICULATION. REVISION SURGERY. PATIENT INVOLVED. REVIEW OF RECEIVED DATA: NO EVALUATION OF THE PICTURES/X-RAYS AS THE REPORTED EVENT IS ALREADY KNOWN AND ADDRESSED. DUE DILIGENCE: NO FURTHER DUE DILIGENCE REQUIRED AS ALL REQUIRED INFORMATION TO SUPPORT THE CONCLUSION IS AVAILABLE OR WAS ALREADY REQUESTED. PRODUCT EVALUATION: VISUAL EXAMINATION: NO PRODUCT WAS RETURNED FOR VISUAL EXAMINATION. REVIEW OF PRODUCT DOCUMENTATION: DEVICE PURPOSE: THIS DEVICE IS INTENDED FOR TREATMENT. DHR REVIEW: REVIEW OF THE DEVICE HISTORY RECORDS DID NOT IDENTIFY ANY DEVIATIONS OR ANOMALIES DURING MANUFACTURING. CONCLUSION: NO FURTHER INVESTIGATION REQUIRED AS THIS ISSUE IS KNOWN AND ADDRESSED (ERROR PATTERN: POTENTIAL EARLY REVISION OF THE ACETABULAR COMPONENT DUE TO LOOSENING, IMPLANT MIGRATION OR UNRESOLVED PAIN, HIGHER ION RELEASE). MOST LIKELY ROOT CAUSE FOR THE REPORTED EVENT IS INAPPROPRIATE USE/IMPLANTATION OF THE PRODUCT. SHOULD ANY ADDITIONAL INFORMATION THAT CHANGES THE ASSESSMENT BECOME AVAILABLE TO US, OR ANY EXTRA DEMAND BE REQUESTED, WE WILL RE-EVALUATE THE CASE. SINCE THIS CASE IS RELATED TO THE ISSUES FOR WHICH ZIMMER IMPLEMENTED A NOTIFICATION IN JULY 2008 AS REFERENCED ABOVE IN H7 AND H9, ZIMMER GMBH WILL CLOSE THIS CASE ONCE AGAIN. ZIMMER BIOMET¿S REFERENCE NUMBER OF THIS FILE IS (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT, RIGHT HIP PAINFUL HIP/FAILED ARTHROPLASTY WITH METAL ON METAL ARTICULATION. PATIENT OUTCOME - REVISION DUE TO PAIN.

    Description of Event or Problem · 0

    NO CHANGE TO PREVIOUSLY REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    900778 METASUL® LDH®, HEAD ADAPTER, XL, +8, TAPER 12/14-18/20 DUROM ACETABULAR COMPONENT AND METASUL LDH LARGE DIAMETER HEADS KWA ZIMMER SWITZERLAND MANUFACTURING GMBH N/A 2316472

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Hospitalization| R SEE H10 NARRATIVE