MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PFC*SIGMA C/R NPOR FEM LT SZ 3; SIGMA KNEE PRIMARY : KNEE FEMORAL

Model Number	96-0003
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Fall (1848); Limb Fracture (4518); Unspecified Tissue Injury (4559)
Date of Event	10/15/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
Clinical notification received for revision of left total knee to address periprosthetic distal supracondylar femur fracture - degloving injury.Date of implantation: (b)(6) 2005.Date of revision: (b)(6) 2021.(left knee) treatment: femur, tibial tray, and insert components revised.On (b)(6) 2005, the patient had a left cemented total knee arthroplasty to address osteoarthritis, end-stage with significant arthrofibrosis.Depuy components including depuy patella were used in this procedure.On (b)(6) 2021, the patient had a revision left total knee arthroplasty to address left periprosthetic supracondylar femur fracture.The patient had a fall and wanted to have significant osteoporosis.The surgeon observed a displaced and slightly comminuted supracondylar femur fracture and a degloving injury to the subcutaneous tissue proximal medial tibia and large subcutaneous hemorrhage.The tibial tray, insert and femoral components were revised.Competitor components were placed, along with depuy cement during this procedure.
Additional Manufacturer Narrative
Product complaint # (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.All available x-rays were reviewed, and no evidence of implant fracture, disassociation, or anything indicative of a device nonconformance was found.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.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.

• Common Device Name: SIGMA KNEE PRIMARY : KNEE FEMORAL
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDICS 1818910; 700 orthopaedic dr; warsaw IN 46581 0988
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 12854572
• Report Number: 1818910-2021-26074
• Device Sequence Number: 17389098
• Product Code: JWH
• UDI-Device Identifier: 10603295231950
• UDI-Public: 10603295231950
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K943462
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2005
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 96-0003
• Device Catalogue Number: 960003
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/27/2021
• Supplement Date Received by Manufacturer: 12/14/2021
• Initial Report FDA Received Date: 11/22/2021
• Supplement Report FDA Received Date: 12/14/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: PFC*SIGMA C/R NPOR FEM LT SZ 3; PFC*SIGMA/OV/DOME PAT 3PEG,38; SIG MOD TIB TRAY CEM COCR 3; SIGMA CRVD XLK INS 3 8MM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 81 YR
• Patient Sex: Female
• Patient Weight: 91 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White