MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SIGMA STAB XLK INS 4 12.5MM; SIGMA KNEE PRIMARY : KNEE TIBIAL INSERT

Model Number	1581-24-112
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Edema (1820); Pain (1994); No Code Available (3191)
Date of Event	08/18/2020
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
On tuesday, (b)(6) 2020.Surgeon performed a revision knee arthroplasty on the right knee of a patient.Surgeon had performed the index surgery on the right knee of the patient in 2011.Since the index surgery, patient has complained of pain, some instability, and mild effusion.Surgeon elected to revise the right knee on (b)(6) 2020.Upon exposure to the joint space surgeon examined the patellar and tibial component and determined they were well fixed and elected to leave them implanted.With minimal mechanical effort, surgeon was able to explant the femoral component which was generally clean of the competitor cement except on the posterior condyles where cement remained attached.Surgeon then prepared the remaining bone to accept a revision femoral component and reimplanted.No instruments broke during the procedure.There were no delays in relation to depuy.There was no suggestion that the implants did not perform as expected.There was no noticeable poly wear.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.A worldwide complaint database search found no other related reported incidents against the provided product code/lot number combination since release for distribution.Based on previous investigations, this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.

• Brand Name: SIGMA STAB XLK INS 4 12.5MM
• Common Device Name: SIGMA KNEE PRIMARY : KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 10454983
• Report Number: 1818910-2020-18808
• Device Sequence Number: 4093176
• Product Code: JWH
• UDI-Device Identifier: 10603295064503
• UDI-Public: 10603295064503
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K040166
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/18/2020

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: 1581-24-112
• Device Catalogue Number: 158124112
• Device Lot Number: E3GMV1
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/18/2020
• Supplement Date Received by Manufacturer: 10/06/2020
• Initial Report FDA Received Date: 08/26/2020
• Supplement Report FDA Received Date: 10/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SIGMA PS FEMUR SZ4 R; SIGMA STAB XLK INS 4 12.5MM; STRYKER CEMENT; SIGMA PS FEMUR SZ4 R; SIGMA STAB XLK INS 4 12.5MM; STRYKER CEMENT
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 68 YR
• Patient Weight: 98