BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OXF UNI TIB TRAY SZ B RM PMA

    MDR report key: 9063816 · Received September 15, 2019

    Report

    Report Number
    3002806535-2019-00747
    Event Type
    Injury
    Date Received
    September 15, 2019
    Date of Event
    August 28, 2019
    Report Date
    May 5, 2020
    Manufacturer
    BIOMET UK LTD.
    Product Code
    NRA
    UDI-DI
    05019279388875
    PMA / PMN Number
    P010014
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FINAL REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. D11: MEDICAL PRODUCT: OXF TWIN-PEG CMNTD FEM MD PMA, CATALOG #: 161469, LOT #: 221790. MEDICAL PRODUCT: OXF ANAT BRG RT MD SIZE 4 PMA, CATALOG #: 159576, LOT #: 933560. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 3002806535-2019-00746-1, 3002806535-2019-00748-1. PRODUCTS IMPLANTED DURING REVISION SURGERY: 183008, LOT J6578408 VANGUARD CR ILOK FEM-RT 65. 185204, LOT 923780 BMT 360 TIB TRAY 75MM. 184764, LOT 543150 SERIES A PAT STD 31. 185650, LOT 166310 BMT 360 TIB SM CRUCIATE WING. 183442, LOT 671390 VNGD R TIB BRG 12X71/75. 148306, LOT 000290 BMT SPLINED KNEE STM V2 16X80. PRODUCTS HAVE BEEN RETURNED TO BIOMET UK LTD FOR EVALUATION AND FORWARDED TO A RESEARCH ENGINEER FOR INVESTIGATION. PRODUCT EVALUATION REVIEW: A RIGHT OXFORD PARTIAL KNEE SYSTEM WAS REVISED AFTER APPROXIMATELY 3 YEARS AND 3 MONTHS DUE TO UNKNOWN REASONS. VISUAL EXAMINATION OF THE FEMORAL COMPONENT SHOWED THE PRESENCE OF LIGHT SCRATCHES ON THE ARTICULATING SURFACE. THE CEMENT POCKET, BUT NOT THE PEGS, WAS COVERED BY UNEVEN BUT WELL ATTACHED CEMENT, WHICH OVERHUNG FROM ITS SIDES. THE ARTICULATING SURFACE OF THE TIBIAL TRAY WAS IN OVERALL GOOD CONDITION. CEMENT WAS ONLY PRESENT LATERALLY TO AND THROUGH THE KEEL, ALTHOUGH IT IS NOT CLEAR WHETHER THE MAJORITY OF THE CEMENT MANTLE DETACHED BEFORE, DURING OR AFTER REVISION SURGERY. THE MENISCAL BEARING SHOWS SIGNS OF SEVERE PITTING ON BOTH SUPERIOR AND INFERIOR ARTICULATING SURFACES, AS WELL AS SOME SCRATCHES IN THE AP DIRECTION ON THE INFERIOR SURFACE. THESE ARE CONSISTENT WITH ARTICULATION AGAINST THIRD BODY DEBRIS SUCH AS OSTEOPHYTES AND/OR BONE CEMENT. THERE IS ALSO EVIDENCE OF SOME DAMAGE TO THE LATERAL WALL OF THE BEARING, LIKELY CAUSED DURING IMPLANT REMOVAL DURING REVISION. THE BEARING DIMENSIONS WERE MEASURED WITH DIGITAL CALLIPERS AND IT WAS FOUND THAT THE THICKNESS OF THE ANTERIOR AND POSTERIOR EDGES INCREASED, WHILE THAT OF THE THINNEST PART DECREASED. INCREASES IN BEARING THICKNESS HAVE BEEN DESCRIBED IN BEARINGS WHICH HAVE BEEN AUTOCLAVED, WHICH IS THE CASE OF THIS BEARING, AS STATED IN THE PRODUCT SURVEILLANCE LAB WORK REQUEST FORM RETURNED WITH THE COMPONENTS. NEVERTHELESS, THE DECREASE IN THICKNESS OF THE THINNEST PART OF THE BEARING SUGGESTS CONSIDERABLE WEAR. DEVICE HISTORY RECORD REVIEW: THE MHR RELATED TO THE INVOLVED PRODUCTS HAVE BEEN REVIEWED AND DO NOT SHOW ANY NON-CONFORMITY, REJECTION OR CONCESSION THAT COULD BE RELATED TO THE REPORTED EVENT. IMPLANT COMPATIBILITY REVIEW: ALL REPORTED COMPONENTS ARE COMPATIBLE. CORRECTIVE ACTION, PREVENTIVE ACTION, AND/OR FIELD ACTION: NO CORRECTIVE OR PREVENTIVE ACTIONS ARE CONSIDERED NECESSARY AT THIS TIME. IFU AND/OR SURGICAL PROCEDURE REFERENCE: IFU 5401000269 REV 3 AND IFU 5401000201 REV L. THE INSTRUCTIONS FOR USE PROVIDED WITH THE OXFORD PARTIAL KNEE SYSTEM PROVIDES THE FOLLOWING GUIDANCE: WARNINGS: IMPROPER SELECTION, PLACEMENT, POSITIONING, ALIGNMENT AND FIXATION OF THE IMPLANT COMPONENTS MAY RESULT IN UNUSUAL STRESS CONDITIONS WHICH MAY LEAD TO SUBSEQUENT REDUCTION IN THE SERVICE LIFE OF THE PROSTHETIC COMPONENTS. CARE IS TO BE TAKEN TO ENSURE COMPLETE SUPPORT OF ALL PARTS OF THE DEVICE EMBEDDED IN BONE CEMENT TO REDUCE RISK OF STRESS CONCENTRATIONS, WHICH MAY LEAD TO FAILURE OF THE PROCEDURE. COMPLETE PRECLOSURE CLEANING AND REMOVAL OF BONE CEMENT DEBRIS, METALLIC DEBRIS, AND OTHER SURGICAL DEBRIS AT THE IMPLANT SITE IS CRITICAL TO MINIMIZE WEAR OF THE IMPLANT ARTICULAR SURFACES. IMPLANT FRACTURE AND LOOSENING DUE TO CEMENT FAILURE HAS BEEN REPORTED. PRECAUTIONS: BIOMET JOINT REPLACEMENT PROSTHESES PROVIDE THE SURGEON WITH A MEANS OF REDUCING PAIN AND RESTORING FUNCTION FOR MANY PATIENTS. WHILE THESE DEVICES ARE GENERALLY SUCCESSFUL IN ATTAINING THESE GOALS THEY CANNOT BE EXPECTED TO WITHSTAND THE ACTIVITY LEVELS OF NORMAL HEALTHY BONE AND JOINT TISSUE. ACCEPTED PRACTICES IN POSTOPERATIVE CARE ARE IMPORTANT. FAILURE OF THE PATIENT TO FOLLOW POSTOPERATIVE CARE INSTRUCTIONS INVOLVING REHABILITATION CAN COMPROMISE THE SUCCESS OF THE PROCEDURE. THE PATIENT IS TO BE ADVISED OF THE LIMITATIONS OF THE RECONSTRUCTION AND THE NEED FOR PROTECTION OF THE IMPLANTS FROM FULL LOAD BEARING UNTIL ADEQUATE FIXATION AND HEALING HAVE OCCURRED. EXCESSIVE ACTIVITY, TRAUMA AND WEIGHT GAIN MAY CONTRIBUTE TO PREMATURE FAILURE OF THE IMPLANT BY LOOSENING, FRACTURE, AND/OR WEAR. POSSIBLE ADVERSE EFFECTS: PARTICULATE WEAR DEBRIS AND DISCOLORATION FROM METALLIC AND POLYETHYLENE COMPONENTS OF JOINT IMPLANTS MAY BE PRESENT IN ADJACENT TISSUE OR FLUID. IT HAS BEEN REPORTED THAT WEAR DEBRIS MAY INITIATE A CELLULAR RESPONSE RESULTING IN OSTEOLYSIS OR OSTEOLYSIS MAY BE A RESULT OF LOOSENING OF THE IMPLANT. LOOSENING OR MIGRATION OF THE IMPLANTS CAN OCCUR DUE TO LOSS OF FIXATION, TRAUMA, MALALIGNMENT, BONE RESORPTION, EXCESSIVE ACTIVITY. WEAR AND/OR DEFORMATION OF ARTICULATING SURFACES. RISK ASSESSMENT: THE EVENT REPORTS REVISION DUE TO UNKNOWN REASON. FAILURE ANALYSIS REPORT 564, REV 1. CONCLUDES A RIGHT OXFORD PARTIAL KNEE SYSTEM WAS REVISED AFTER APPROXIMATELY 3 YEARS AND 3 MONTHS OF IMPLANTATION DUE TO UNKNOWN REASONS. IMPLANT EXAMINATION SUGGESTS THAT THE BEARING MAY HAVE ARTICULATED AGAINST THIRD BODY DEBRIS SUCH AS OSTEOPHYTES AND/OR BONE CEMENT FRAGMENTS, AND THAT THE CEMENT FIXATION OF THE TIBIAL TRAY MAY HAVE BEEN SUB-OPTIMAL. HOWEVER, THIS CANNOT BE CONFIRMED WITHOUT ADDITIONAL INFORMATION BEING PROVIDED SUCH AS SURGICAL NOTES, PATIENT AND ACTIVITY DETAILS, AS WELL AS POST-PRIMARY AND PRE-REVISION RADIOGRAPHS. SINCE THE HARM OR REASON FOR REVISION HAS NOT BEEN BE REPORTED, A ROOT CAUSE CANNOT BE DETERMINED, THEREFORE A SPECIFIC FAILURE CAUSE WITHIN THE RISK TABLE CANNOT BE SELECTED FOR COMPARISON. IF FURTHER INFORMATION REGARDING THE ROOT CAUSE OF THE REPORTED EVENT OR REASON FOR REVISION ARE PROVIDED, THE RISK WILL BE RE-ASSESSED. CONCLUSION: A RIGHT OXFORD PARTIAL KNEE SYSTEM WAS REVISED AFTER APPROXIMATELY 3 YEARS AND 3 MONTHS OF IMPLANTATION DUE TO UNKNOWN REASONS. THE RELEVANT MANUFACTURING HISTORY RECORDS INDICATE THAT THE PARTS WERE MANUFACTURED AND STERILISED IN ACCORDANCE WITH THE APPLICABLE SPECIFICATIONS. IMPLANT EXAMINATION SUGGESTS THAT THE BEARING MAY HAVE ARTICULATED AGAINST THIRD BODY DEBRIS SUCH AS OSTEOPHYTES AND/OR BONE CEMENT FRAGMENTS, AND THAT THE CEMENT FIXATION OF THE TIBIAL TRAY MAY HAVE BEEN SUB-OPTIMAL. THIS HOWEVER CANNOT BE CONFIRMED WITHOUT ADDITIONAL INFORMATION BEING PROVIDED SUCH AS SURGICAL NOTES, PATIENT AND ACTIVITY DETAILS, AS WELL AS POST-PRIMARY AND PRE-REVISION RADIOGRAPHS. THE MHR REVIEW INDICATES THAT THE PRODUCT WAS MOST LIKELY CONFORMING TO DESIGN SPECIFICATION WHEN IT LEFT ZIMMER BIOMET CONTROL, AND THE LIKELY FAILURE MODE IS BEARING ARTICULATION AGAINST THIRD BODY DEBRIS. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN INITIAL KNEE ARTHROPLASTY. SUBSEQUENTLY,THE PATIENT WAS REVISED DUE TO AN UNKNOWN REASONS.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCT(S): MEDICAL PRODUCT: OXF TWIN-PEG CMNTD FEM MD PMA CATALOG #: 161469 LOT #: 221790; MEDICAL PRODUCT: OXF ANAT BRG RT MD SIZE 4 PMA CATALOG #: 159576 LOT #: 933560; PRODUCTS IMPLANTED DURING REVISION SURGERY: 183008, LOT J6578408 VANGUARD CR ILOK FEM-RT 65; 185204, LOT 923780 BMT 360 TIB TRAY 75MM; 184764, LOT 543150 SERIES A PAT STD 31; 185650, LOT 166310 BMT 360 TIB SM CRUCIATE WING; 183442, LOT 671390 VNGD R TIB BRG 12X71/75; 148306, LOT 000290 BMT SPLINED KNEE STM V2 16X80, CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN THE PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ONCE THE INVESTIGATION IS COMPLETE, A SUPPLEMENTAL MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 3002806535-2019-00746, 3002806535-2019-00748 THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION IS COMPLETE, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN INITIAL KNEE ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT WAS REVISED DUE TO AN UNKNOWN REASONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    861513 OXF UNI TIB TRAY SZ B RM PMA KNEE PROSTHESIS NRA BIOMET UK LTD. N/A 821370 05019279388875

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R