BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PFC*SIGMA/OV/DOME PAT 3PEG,35

    MDR report key: 20558789 · Received October 29, 2024

    Report

    Report Number
    1818910-2024-22565
    Event Type
    Injury
    Date Received
    October 29, 2024
    Date of Event
    October 8, 2024
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    JWH
    UDI-DI
    10603295232612
    PMA / PMN Number
    P830055
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT (B)(4). INVESTIGATION SUMMARY: NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. THE PRODUCT INVESTIGATION FOUND NO EVIDENCE SUSPECTING AN ERROR IN THE MANUFACTURING OR MATERIAL THAT WOULD BE A CONTRIBUTING FACTOR IN THE REPORTED ALLEGATION(S). A RECORDS EVALUATION (MRE) WAS NOT PERFORM. AS PART OF OUR COMPANY QUALITY SYSTEM PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND DISTRIBUTED TO APPROVED SPECIFICATIONS. ADDITIONAL COMPLAINT INFORMATION MONITORING FOR POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AS PART OF THE POST-MARKET SURVEILLANCE. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. DEVICE HISTORY LOT: THE PRODUCT INVESTIGATION FOUND NO EVIDENCE SUSPECTING AN ERROR IN THE MANUFACTURING OR MATERIAL THAT WOULD BE A CONTRIBUTING FACTOR IN THE REPORTED ALLEGATION(S). A MANUFACTURING RECORDS EVALUATION (MRE) WAS NOT PERFORMED.

    Additional Manufacturer Narrative · 0

    DEPUY ORTHOPAEDICS IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY ORTHOPAEDICS HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY ORTHOPAEDICS OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY ORTHOPAEDICS, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 0

    SUBJECT ID: (B)(6). STUDY NO: DOTS: CLINICAL ADVERSE EVENTS RECEIVED FOR CONTINUED PAIN, PINCHING SENSATION DEVICE AND PROCEDURE(RELATEDNESS). DEVICE RELATED: POSSIBLY. PROCEDURE RELATED: REMOTE POSSIBILITY. DATE OF EVENT: 8/OCT/2024 DATE OF IMPLANT: NO INFORM.ATION PROVIDED. DATE OF REVISION: NO INFORMATION PROVIDED. DEVICE LOCATION: RIGHT. TREATMENT/IMPACT: SURGICAL EXPLORATION OF THE FEMUR AND DEBRIDEMENT OF THE FAT PAD. DEPUY COMPONENTS USED IN PROCEDURE WITHOUT DATE OF REVISION: CATALOG ID: 129433130, LOT ID: 9744770, COMPONENT TYPE: TIBIAL, DESCRIPTION: MBT CEMENTED KEEL SZ 3. CATALOG ID: 940023, LOT ID: J50C75, COMPONENT TYPE: FEMORAL, DESCRIPTION: SIGMA FEM C/RET POROCOAT SZ 3 RT. CATALOG ID: 960101, LOT ID: D20101506, COMPONENT TYPE: PATELLAR, DESCRIPTION: SIGMA PATELLA OVAL DOME 3 PEGGED 35MM. CATALOG ID: 3322020, LOT ID: 9524034, COMPONENT TYPE: CEMEN,T DESCRIPTION: SMART SET BONE CEMENT 20G. CATALOG ID: 3322020, LOT ID: 9448053, COMPONENT TYPE: CEMENT, DESCRIPTION: SMART SET BONE CEMENT 20G. CATALOG ID: 196192034, LOT ID: 9137529, COMPONENT TYPE: INSERT, DESCRIPTION: AOX CVD RP TIBIAL INSERT SZ 3 17.5MM. THE PATIENT STATUS POST: RIGHT KNEE REPLACEMENT/REVISION KNEE REPLACEMENT. THE PATIENT INITIALLY DID QUITE WELL, UNFORTUNATELY, AFTER SURGERY SHE WAS INVOLVED IN A MOTOR VEHICLE ACCIDENT AND THEN DEVELOPED INSTABILITY WHICH WARRANTED A REVISION. THE POLY INSERT WAS REVISED. THE PATIENT DID WELL AFTER SURGERY, BUT CONTINUES TO HAVE PAIN AND DISCOMFORT AROUND THE KNEE. PATIENT ALSO REPORTS NUMBNESS IN THIGH RELATED TO MERALGIA PARESTHETICA. THE SURGEON¿S IMPRESSION IS POSSIBLE PINCHING OF THE FAT PAD WITH REACTIVE BONE CHANGES PROXIMAL TO THE FEMUR. THE SURGEON IS GOING TO EXPLORE AND DEBRIDE THE FAT PAD AND EXPLORE THE FEMUR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    915489 PFC*SIGMA/OV/DOME PAT 3PEG,35 SIGMA KNEE PRIMARY : KNEE PATELLA JWH DEPUY ORTHOPAEDICS INC US D20101506 10603295232612

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Female Required Intervention