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 Codes	Erythema (1840); Unspecified Infection (1930); Inflammation (1932); Pain (1994); No Consequences Or Impact To Patient (2199); Fluid Discharge (2686); No Code Available (3191)
Date of Event	08/22/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(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
Clinical notification received for revision of right knee to address infection.Date of implantation: (b)(6) 2020.Date of revision: (b)(6) 2020; (right knee).Treatment: revision of tibial insert.
Additional Manufacturer Narrative
Product complaint # (b)(4).This product was reported in error since mrn 1818910-2020-19947 was found to be a duplicate report of mrn 1818910-2020-19543.Depuy considers the investigation closed at this time.Should any additional information be received to change the outcome of the performed investigation, the complaint will be re-opened.

• 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: 10527878
• Report Number: 1818910-2020-19947
• Device Sequence Number: 11526863
• 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: K040166
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• 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): 08/27/2020

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: 1581-02-112
• Device Catalogue Number: 158102112
• Device Lot Number: 8943702
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/01/2020
• Supplement Date Received by Manufacturer: 10/07/2020
• Initial Report FDA Received Date: 09/14/2020
• Supplement Report FDA Received Date: 10/12/2020
• 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: 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; 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 81 YR
• Patient Weight: 93