MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SIGMA PLI XLK INS 2.5 12.5MM; SIGMA KNEE PRIMARY : KNEE TIBIAL INSERT

Model Number	1581-02-112
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	06/05/2021
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
Subject id: (b)(4).Study: (b)(4).Clinical notification received for revision to address infection date of implantation: (b)(6) 2020.Date of revision: (b)(6) 2021.(right knee) treatment: revision, removal of all implants, with placement of an antibiotic spacer product details: catalog: 158102112.Lot: 8943702.Description: sigma bannister p/lipped xlk insert 2.5 12.5mm.Catalog: 960018.Lot: d18102253.Description: sigma fem c/ret cemented rt sz 2.5.Catalog: 158125000.Lot: 9472648.Description: sigma bannister tibial tray cemented sz 2.5.Catalog: 3312040.Lot: 9282835.Description: smart set cmw 1 40g.Catalog: 3312040.Lot: 9282835.Description: smart set cmw 1 40g.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.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.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will 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.

• Brand Name: SIGMA PLI XLK INS 2.5 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: 12027350
• Report Number: 1818910-2021-13055
• Device Sequence Number: 13796666
• Product Code: JWH
• UDI-Device Identifier: 10603295062448
• UDI-Public: 10603295062448
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K082500
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional,study
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/09/2021

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: 1581-02-112
• Device Catalogue Number: 158102112
• Device Lot Number: 8943702
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/09/2021
• Supplement Date Received by Manufacturer: 08/02/2021
• Initial Report FDA Received Date: 06/18/2021
• Supplement Report FDA Received Date: 08/03/2021
• 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: DEPUY CMW 1 40G; DEPUY CMW 1 40G; PFC*SIGMA C/R NPOR FE RT SZ2.5; SIG MOD TIB TRAY CEM COCR 2.5; SIGMA PLI XLK INS 2.5 12.5MM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 82 YR
• Patient Weight: 93