BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKN JOINT REPAIR DEV

    MDR report key: 23979360 · Received January 6, 2026

    Report

    Report Number
    1219602-2026-00047
    Event Type
    Injury
    Date Received
    January 6, 2026
    Report Date
    February 23, 2026
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    MBI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    H11: INTERNAL COMPLAINT REFERENCE (B)(4). BASED ON THE INFORMATION PROVIDED, MULTIPLE PRODUCT NUMBERS AND LOTS WERE IDENTIFIED AS POTENTIALLY ASSOCIATED WITH THE REPORTED ADVERSE EVENTS. THE PATIENTS ARE FROM THREE DIFFERENT UNSPECIFIED HOSPITALS. HOWEVER, DEVICE TRACEABILITY BETWEEN INDIVIDUAL PATIENTS, HOSPITALS, SPECIFIC PART NUMBERS, AND LOT NUMBERS COULD NOT BE ESTABLISHED. THE POTENTIALLY INVOLVED PRODUCT NUMBERS AND LOTS ARE THE FOLLOWING: PN 72290001: LOT 2161372 (1 UNIT / MFG. DATE: 16-AUG-2024, EXP. DATE: 16-AUG-2027). LOT 2140007 (1 UNIT / MFG. DATE: 10-JAN-2024, EXP. DATE: 10-JAN-2027). LOT 2161136 (1 UNIT / MFG. DATE: 01-AUG-2024, EXP. DATE: 01-AUG-2027). PN 72205127: LOT 2174291 (1 UNIT / MFG. DATE: 16-JAN-2025, EXP. DATE: 16-JAN-2030). PN 72205135: LOT 2150371 (1 UNIT / MFG. DATE: 14-APR-2024, EXP. DATE: 14-APR-2027), LOT 2183141 (1 UNIT / MFG. DATE: 08-MAY-2025, EXP. DATE: 08-MAY-2028), LOT 2175763 (1 UNIT / MFG. DATE: 08-FEB-2025, EXP. DATE: 08-FEB-2028), LOT 2183544 (1 UNIT / MFG. DATE: UNKNOWN, EXP. DATE: UNKNOWN), LOT 2161517 (1 UNIT / MFG. DATE: 07-AUG-2024, EXP. DATE: 07-AUG-2027), LOT 2186366 (2 UNITA / MFG. DATE: 12-JUL-2025, EXP. DATE: 12-JUL-2028). PN 72203707: LOT 2165078 (1 UNIT / MFG. DATE: 03-OCT-2024, EXP. DATE: 03-OCT-2027), LOT 2162242 (1 UNIT / MFG. DATE: 14-AUG-2024, EXP. DATE: 14-AUG-2027), LOT 2181704 (1 UNIT / MFG. DATE: 17-MAR-2025, EXP. DATE: 17-MAR-2028), LOT 2181727 (1 UNIT / MFG. DATE: 03-APR-2025, EXP. DATE: 03-APR-2028), LOT 2185187 (1 UNIT / MFG. DATE: 12-JUN-2025, EXP. DATE: 12-JUN-2028). DUE TO THE NONSPECIFIC NATURE OF THE ORIGINAL REPORT, THE LACK OF RETURNED DEVICES, AND THE INABILITY TO DIFFERENTIATE DEVICES BY PATIENT OR FAILURE OUTCOME, IT IS NOT POSSIBLE TO ASSOCIATE ANY SPECIFIC PRODUCT NUMBER OR LOT WITH A PARTICULAR CLINICAL OUTCOME. THEREFORE, ALL LISTED PRODUCT NUMBERS AND LOTS REMAIN POTENTIALLY INVOLVED. THE CASE WILL BE UPDATED IF ADDITIONAL INFORMATION BECOMES AVAILABLE. H3, H6: THIS COMPLAINT WAS OPENED BY SMITH+NEPHEW TO DOCUMENT A PATIENT COMPLICATION REPORTED THAT INCLUDES REFERENCE TO THE USE OF A SMITH+NEPHEW PRODUCT WITHOUT EVIDENCE ABOUT A SPECIFIC PRODUCT PROBLEM. THE REPORTED COMPLICATION RELATES TO KNOWN INHERENT PROCEDURAL RISKS THAT ARE APPROPRIATELY DOCUMENTED IN OUR RISK FILES. SMITH+NEPHEW WILL CONTINUE TO MONITOR TRENDS IN ACCORDANCE WITH OUR POST-MARKET SURVEILLANCE PROCESS AND TAKE NECESSARY ACTION AS REQUIRED IF ANTICIPATED SEVERITY AND/OR OCCURRENCE RATES ARE EXCEEDED. SMITH+NEPHEW HAS NO REASON TO SUSPECT THAT THE PRODUCT FAILED TO MEET ANY SPECIFICATIONS AT THE TIME OF MANUFACTURE. BASED ON OUR REVIEW OF ALL CURRENTLY AVAILABLE INFORMATION, WE ARE UNABLE TO CONFIRM A RELATIONSHIP BETWEEN THE REPORTED EVENT AND THE DEVICE OR IDENTIFY A DEFINITIVE ROOT CAUSE. HOWEVER, AS THE USE OF OUR PRODUCT CANNOT BE EXCLUDED AS A POTENTIAL CAUSE OR CONTRIBUTORY FACTOR TO THE REPORTED ISSUE, WE ARE SUBMITTING THIS REPORT IN ACCORDANCE WITH APPLICABLE REGULATIONS. IF ADDITIONAL INVESTIGATIVE FINDINGS OR INFORMATION BECOMES AVAILABLE THAT ALTERS THE CONCLUSIONS OF THIS REPORT, A FOLLOW-UP REPORT WILL BE SUBMITTED AS REQUIRED.

    Additional Manufacturer Narrative · 0

    H11: H3, H6: A DEVICE DEFICIENCY WAS NOT IDENTIFIED, AND THE ROOT CAUSE OF THE REPORTED EVENT COULD NOT BE DETERMINED SINCE THE DEVICES WERE NOT RETURNED FOR EVALUATION. ONE OF THE PROVIDED PRODUCT IDENTIFICATION DETAILS: LOT 2183544 DID NOT MATCH ANY KNOWN RELEASE OF PART 72205135 AND THUS A MANUFACTURING RECORD REVIEW COULD NOT BE CONDUCTED FOR THIS DEVICE. BASED ON THE INFORMATION AVAILABLE, THERE WERE NO INDICATIONS TO SUGGEST THAT THIS PRODUCT DID NOT MEET MANUFACTURING SPECIFICATIONS UPON RELEASE FOR DISTRIBUTION. A REVIEW OF DEVICE RECORDS AND STERILIZATION RECORDS FOR THE REMAINING DEVICES SHOWED THERE WERE NO INDICATIONS TO SUGGEST THAT THE PRODUCT DID NOT MEET MANUFACTURING SPECIFICATIONS UPON RELEASE FOR DISTRIBUTION. A COMPLAINT HISTORY REVIEW FOUND NO SIMILAR REPORTED EVENTS. THE INSTRUCTIONS FOR USE WERE REVIEWED AND FOUND TO INCLUDE CONDITIONS OF OFF LABEL USE AND TECHNIQUE SPECIFICS, AS WELL AS PRECAUTIONS AND WARNINGS RELATED TO THE USE OF THE DEVICES. A RISK MANAGEMENT REVIEW FOUND THAT THE REPORTED FAILURE AND/OR HARM WAS DOCUMENTED APPROPRIATELY, AND THERE WERE NO INDICATIONS TO SUGGEST THE ANTICIPATED RISK IS NOT ADEQUATE. PLEASE REFER TO THE INSTRUCTIONS FOR USE FOR PRECAUTIONS AND WARNINGS RELATED TO THE USE OF THE DEVICES. BASED ON THIS INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. IF ANY ADDITIONAL INFORMATION RELATED TO THIS EVENT IS RECEIVED IN THE FUTURE, THIS INVESTIGATION WILL BE REOPENED FOR EVALUATION.

    Additional Manufacturer Narrative · 0

    H11: H3, H6: A DEVICE DEFICIENCY WAS NOT IDENTIFIED, AND THE ROOT CAUSE OF THE REPORTED EVENT COULD NOT BE DETERMINED DUE TO THE LIMITED CLINICAL INFORMATION PROVIDED. INSUFFICIENT PRODUCT IDENTIFICATION INFORMATION WAS PROVIDED AND THUS A MANUFACTURING RECORD AND STERILIZATION RECORD REVIEW, COMPLAINT HISTORY REVIEW, RISK MANAGEMENT REVIEW AND INSTRUCTIONS FOR USE REVIEW, COULD NOT BE CONDUCTED. BASED ON THE INFORMATION AVAILABLE, THERE WERE NO INDICATIONS TO SUGGEST THAT THE PRODUCT DID NOT MEET MANUFACTURING SPECIFICATION UPON RELEASE FOR DISTRIBUTION. BECAUSE OF THE LIMITED INFORMATION PROVIDED WE ARE UNABLE TO CONCLUDE FACTORS KNOWN TO CONTRIBUTE TO THE ALLEGED REPORT. BASED ON THIS INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AFTER IMPLANTING ANCHOR DEVICES, A PATIENT EXPERIENCED A POST-OPERATIVE INFECTION THAT REQUIRED A SURGICAL WASHOUT. THE OUTCOME AND CURRENT CONDITION OF THE PATIENT ARE UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    616139 UNKN JOINT REPAIR DEV FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE MBI SMITH & NEPHEW, INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention| H| O 72203707| 72205127| 72205135| 72290001