BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZIMMER MMC, CUP, UNCEMENTED, 60 MM/52 MM, CODE R

    MDR report key: 8629271 · Received May 21, 2019

    Report

    Report Number
    0009613350-2019-00314
    Event Type
    Injury
    Date Received
    May 21, 2019
    Date of Event
    April 16, 2014
    Report Date
    November 29, 2019
    Manufacturer
    ZIMMER GMBH
    Product Code
    KWA
    PMA / PMN Number
    K091003
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING FILLED TO RELAY INVESTIGATION RESULT. DHR REVIEW: THE DEVICE MANUFACTURING QUALITY RECORDS INDICATE THAT THE RELEASED COMPONENTS MET ALL REQUIREMENTS TO PERFORM AS INTENDED. TREND ANALYSIS: NO TREND CONSIDERING THE FOLLOWING EVENT IS IDENTIFIED: REVISION DUE TO LOOSENING / METAL REACTION EVENT DESCRIPTION: IT WAS REPORTED THAT A MMC CUP WAS IMPLANTED AS PART OF A THA IN THE RIGHT HIP ON THE (B)(6) 2012 AND REVISED ON THE (B)(6) 2014 DUE TO LOOSENING AND A METAL ON METAL REACTION. REVIEW OF RECEIVED DATA: PRIMARY SURGICAL REPORT DATED (B)(6) 2012 INDICATING DEGENERATIVE OSTEOARTHRITIS OF THE RIGHT HIP AS REASON FOR THE SURGERY. ESTIMATED BLOOD LOSS WAS 350ML. THE MMC ACETABULAR COMPONENT WAS PRESS-FIT WITHIN THE PATIENT'S PELVIS AREA. THE LEG LENGTH WAS EQUIVALENT AND COMPONENTS WERE NOTED TO BEING STABLE. PATIENT WAS TRANSFERRED TO RECOVERY ROOM IN STABLE CONDITION. REVISION SURGRICAL REPORT DATED (B)(6) 2014 INDICATING LOOSE RIGHT TOTAL HIP REPLACEMENT AND A METAL ON METAL REACTION. ESTIMATED BLOOD LOSS WAS 3000ML, HOWEVER NO COMPLICATIONS WERE MENTIONED IN THE SURGICAL REPORT AND THE PATIENT WAS TRANSFERRED TO RECOVERY ROOM IN STABLE CONDITION. FLUID WAS NOTED WITHIN THE TROCHANTERIC BURSA AND WAS SENT FOR CULTURE AND SENSITIVITY. GRAM-STAIN TESTED NEGATIVE FOR ORGANISMS. MUSCLE ATROPHY NOTED, SECONDARY TO THE MOM REACTION. NO EVIDENCE OF ANY METAL DEBRIS, JUST CLEAR FLUID WITH A "FALSE" PSEUDOTUMOR TISSUE, WHICH WAS EXCISED. ACETABULAR COMPONENT NOTED TO BE WELL-FIT. NO MENTIONING OF ANY LOOSENING IN THE SURGICAL REPORT APART FROM THE INDICATION OF SURGERY. LEG-LENGTH WAS EQUIVALENT. THE CUP, LINER AND HEAD WERE REVISED. IMPLANTATION DOCUMENT FROM PRIMARY SURGERY DATED (B)(6) 2012 CONFIRM THE COMPLAINED PRODUCTS. DEVICE ANALYSIS: NO PRODUCT WAS RETURNED TO ZIMMER BIOMET FOR IN-DEPTH ANALYSIS. REVIEW OF PRODUCT DOCUMENTATION: ALL INVOLVED DEVICES ARE INTENDED FOR TREATMENT. THE COMPATIBILITY CHECK WAS PERFORMED AND SHOWED THAT THE PRODUCT COMBINATION WAS APPROVED BY ZIMMER BIOMET. SURGICAL TECHNIQUE: NO DEVIATIONS BETWEEN THE SURGICAL TECHNIQUE AND IMPLANTATION REPORT NOTED. INSTRUCTION FOR USE (IFU): ADVERSE EFFECTS OF THE COMPLAINT ARE COVERED ON PAGE 4 OF THE IFU. WEAR, INFLAMMATORY REACTIONS AND OSTEOLYSIS, AND EARLY OR LATE LOOSENING OF COMPONENTS (ETC.) ARE LISTED. CONCLUSION: IT WAS REPORTED THAT A MMC CUP WAS IMPLANTED AS PART OF A THA IN THE RIGHT HIP ON THE (B)(6) 2012 AND REVISED ON THE (B)(4) 2014 DUE TO LOOSENING AND A METAL ON METAL REACTION. THE QUALITY RECORDS SHOW THAT ALL SPECIFIED CHARACTERISTICS (MATERIAL, DIMENSIONS, SURFACE, ETC.) HAVE MET THE SPECIFICATIONS VALID AT THE TIME OF PRODUCTION. THE REVISION REPORT INDICATES LOOSENING AND METAL ON METAL (MOM) REACTION AS REASON FOR THE REVISION SURGERY, HOWEVER NO FURTHER MENTIONING OF ANY LOOSENING OF ANY OF THE COMPONENTS IS FOUND IN THE REPORT. REGARDING THE EVENT INVOLVING LOOSENING, IT HAS BEEN STATED THAT CIRCUMFERENTIAL BONE FROM AROUND THE WELL-FIT ACETABULAR COMPONENT HAD TO BE REMOVED, SO THAT THE COMPONENT COULD BE REMOVED. THIS COULD INDICATE THAT THE CUP WAS IN FACT ALSO WELL-FIXATED IN THE BONE AND THUS NOT LOOSE. FURTHERMORE, IT HAS NOT BEEN EXPLICITLY INDICATED WHICH COMPONENT WAS LOOSE. IT IS ONLY KNOWN THAT THE CUP, LINER AND HEAD WERE REVISED. REGARDING THE EVENT INVOLVING METAL ON METAL (MOM) REACTION, THERE WERE ONLY INDICATION OF SOME MUSCLE ATROPHY AND A "FALSE" PSEUDOTUMOR. NO METAL DEBRIS WERE FOUND AND THE FLUID WAS CLEAR. DUE TO LIMITED INFORMATION CONTAINED WITHIN THE SURGICAL REPORT IN COMBINATION WITH NO X-RAYS, AND BASED ON THE GIVEN INFORMATION AND THE RESULTS OF THE INVESTIGATION, WE WERE NOT ABLE TO IDENTIFY A SPECIFIC ROOT CAUSE FOR THIS ISSUE. THE NEED FOR CORRECTIVE MEASURES IS NOT INDICATED AND ZIMMER GMBH CONSIDERS THIS CASE AS CLOSED. ZIMMER BIOMET¿S REFERENCE NUMBER OF THIS FILE IS (B)(4).

    Description of Event or Problem · 0

    PLEASE REFER TO INITIAL REPORT.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: ANCHOR SFTISS STATAK, ITEM# 234462, LOT# 234462; FITMORE, HIP STEM, UNCEMENTED, ITEM# 01.00551.307, LOT# 2583487; METASUL LDH, HEAD, ITEM# 01.00181.520, LOT# 2481318; METASUL LDH, HEAD ADAPTER, ITEM# 01.00185.146, LOT# 2597771; HEMOSTAT VITASURE, ITEM# 21140003, LOT# P203002. SURGICAL REPORTS WERE RECEIVED AND WILL BE REVIEWED AS PART OF ONGOING INVESTIGATION. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. 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).

    Description of Event or Problem · 1

    A PATIENT IS PURSUING A PRODUCT LIABILITY CLAIM. THE PATIENT UNDERWENT A REVISION SURGERY DUE TO LOOSENING AND METAL ON METAL REACTION. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    420000 ZIMMER MMC, CUP, UNCEMENTED, 60 MM/52 MM, CODE R ZIMMER MMC CUP KWA ZIMMER GMBH N/A 2528358

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Other| R