BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OXF ANAT BRG LT MD SIZE 5 PMA

    MDR report key: 9615552 · Received January 22, 2020

    Report

    Report Number
    3002806535-2020-00034
    Event Type
    Malfunction
    Date Received
    January 22, 2020
    Date of Event
    December 27, 2019
    Report Date
    April 22, 2020
    Manufacturer
    BIOMET UK LTD.
    Product Code
    NRA
    PMA / PMN Number
    P010014
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. D11: MEDICAL PRODUCT: OXF UNI TIB TRAY SZ D LM PMA, CATALOG #: 154724, LOT #: 342130. MEDICAL PRODUCT: OXF TWIN-PEG CMNTD FEM MD PMA, CATALOG #: 161469, LOT #: 800730. MEDICAL PRODUCT: 1/8 QUICK REL DRL STERILE 2PK, CATALOG #: 32-486265, LOT #: 765430. MEDICAL PRODUCT: STRYKER OP RCP 76.0X11.7, CATALOG #: 277325, LOT #: 313706. MEDICAL PRODUCT: STRYK_76542K_13X90X.89F, CATALOG #: 13-0900-89Y-F1, LOT #: 313261. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FINAL REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. AS THE PRODUCT HAS NOT BEEN RECEIVED, THE INVESTIGATION WAS LIMITED TO THE INFORMATION PROVIDED; A REVIEW OF DEVICE HISTORY RECORDS AND COMPLAINT HISTORY. TWO PRE-REVISION RADIOGRAPHS, THE SAME X-RAYS PROVIDED WITH (B)(4) (TAKEN ON AN UNKNOWN DATE), WERE PROVIDED FOR ANALYSIS WITH (B)(4): ONE ANTEROPOSTERIOR (AP) AND ONE MEDIOLATERAL (ML). ONE OF THE BEARING¿S BALL MARKERS IS VISIBLE IN THE AP X-RAY, WHEREAS THE WIRE AND A BALL MARKER ARE VISIBLE IN THE ML X-RAY, CONFIRMING THAT THE BEARING HAS DISLOCATED INTO THE ANTERIOR JOINT SPACE. THE FEMORAL AND TIBIAL COMPONENTS APPEAR ADEQUATELY SIZED AND POSITIONED, WITH THE POSSIBLE EXCEPTION OF THE TIBIAL TRAY BEING SHORT OF THE POSTERIOR EDGE OF THE TIBIAL PLATEAU. THE OXFORD PARTIAL KNEE SURGICAL TECHNIQUE STATES THAT THE TIBIAL TRAY SHOULD BE FLUSH WITH (OR HAVE LESS THAN 2 MM OVERHANG FROM) THE POSTERIOR EDGE OF THE TIBIAL PLATEAU. THE PATIENT IS MALE AND WAS 69 YEARS OLD AT THE TIME OF PRIMARY SURGERY. IN COMMUNICATIONS WITH THE COMPLAINTS TEAM, IT IS STATED THAT THERE WERE NO CONTRIBUTING CONDITIONS RELATED TO THE EVENT. THE DISLOCATION OF THE 6 MM BEARING, WHICH WAS IMPLANTED TO REPLACE A DISLOCATED 5 MM BEARING ON (B)(6) 2019, SUGGESTS JOINT LAXITY. THE LEFT OXFORD PARTIAL KNEE WAS REVISED TO A VANGUARD TOTAL KNEE ON (B)(6) 2019. THE CAUSE FOR REVISION CANNOT BE DETERMINED WITHOUT FURTHER INFORMATION SUCH AS PATIENT HEIGHT AND WEIGHT, ACTIVITY LEVEL, DATES WHEN THE PROVIDED RADIOGRAPHS WERE TAKEN, AS WELL AS X-RAYS FROM AFTER PRIMARY SURGERY AND THE FIRST REVISION SURGERY. THE MANUFACTURING HISTORY RECORDS (MHRS) FOR THE FEMORAL COMPONENT, TIBIAL TRAY AND ANATOMICAL BEARING HAVE BEEN CHECKED AND VERIFY THAT THE COMPONENTS WERE MANUFACTURED AND STERILISED IN ACCORDANCE WITH THE APPLICABLE SPECIFICATIONS. IN ADDITION, WE HAVE NOT BEEN PROVIDED WITH ANY SUPPORTING DOCUMENTATION WHICH COULD PROVIDE ADDITIONAL INFORMATION. A REVIEW OF THE COMPLAINT DATABASE OVER THE LAST 3 YEARS HAS FOUND 1 SIMILAR COMPLAINT FOUND FOR THE ITEM 159550. THERE WERE NO TRENDS IDENTIFIED FROM THE COMPLAINT HISTORY REVIEW. NO SAME LOT NUMBERS, NO SAME HOSPITALS AND THERE ARE NO TRENDS IN CAUSE. WITHOUT THE OPPORTUNITY TO EXAMINE THE COMPLAINT PRODUCT, ROOT CAUSE CANNOT BE DETERMINED DUE TO INSUFFICIENT INFORMATION. IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE, THEN THE COMPLAINT WILL BE REOPENED AND INVESTIGATED THOROUGHLY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN INITIAL LEFT KNEE ARTHROPLASTY ON (B)(6) 2018. SUBSEQUENTLY, 1ST REVISION WAS PERFORMED ON (B)(6) 2019 AND SECOND REVISION WAS PERFORMED DUE TO POLY DISLOCATION OF BEARING ON (B)(6) 2019. THIS COMPLAINT REPORTS THE SECOND REVISION PERFORMED ON (B)(6) 2019.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN INITIAL LEFT KNEE ARTHROPLASTY ON (B)(6) 2018. SUBSEQUENTLY, 1ST REVISION WAS PERFORMED ON (B)(6) 2019 AND SECOND REVISION WAS PERFORMED DUE TO POLY DISLOCATION OF BEARING ON (B)(6) 2019. THIS COMPLAINT REPORTS THE SECOND REVISION PERFORMED ON (B)(6) 2019.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: MEDICAL PRODUCT: OXF UNI TIB TRAY SZ D LM PMA, CATALOG #: 154724, LOT #: 342130, MEDICAL PRODUCT: OXF TWIN-PEG CMNTD FEM MD PMA, CATALOG #: 161469, LOT #: 800730, MEDICAL PRODUCT: 1/8 QUICK REL DRL STERILE 2PK, CATALOG #: 32-486265, LOT #: 765430, MEDICAL PRODUCT: STRYKER OP RCP 76.0X11.7, CATALOG #: 277325, LOT #: 313706, MEDICAL PRODUCT: STRYK_76542K_13X90X.89F, CATALOG #: 13-0900-89Y-F1, LOT #: 313261. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 3002806535-2020-00035, 3002806535-2020-00036. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL LEFT KNEE ARTHROPLASTY. SUBSEQUENTLY, A REVISION PROCEDURE DUE TO BEARING DISLOCATION WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    77701 OXF ANAT BRG LT MD SIZE 5 PMA KNEE PROSTHESIS NRA BIOMET UK LTD. N/A 561850

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R