MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SIG C/R POROCOAT FEM RT SZ 4; SIGMA KNEE PRIMARY : KNEE FEMORAL

Model Number	94-0024
Medical Device Problem Code	Noise, Audible (3273)
Health Effect - Clinical Codes	Pain (1994); No Code Available (3191)
Date of Event	01/23/2020
Type of Reportable Event	Malfunction
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
On (b)(6) 2019, the patient underwent a right knee revision due to infection, erythema, drainage, dehiscence, and edema.A tibial insert exchange and irrigation and debridement were performed.This was captured in (b)(4).On (b)(6) 2020, the patient presented for a right knee evaluation due to clunking in the knee, pain, instability, and possible spin out of the tibial insert.There is no evidence of a second revision or invasive treatment after the first revision.
Additional Manufacturer Narrative
Product complaint # (b)(4).This is a duplicate report of 1818910-2020-04647.1818910-2020-05872 is being retracted as it is a report duplication.1818910-2020-04647 will be kept for investigation purposes.

• Brand Name: SIG C/R POROCOAT FEM RT SZ 4
• Common Device Name: SIGMA KNEE PRIMARY : KNEE FEMORAL
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 9749846
• Report Number: 1818910-2020-05872
• Device Sequence Number: 16328868
• Product Code: JWH
• UDI-Device Identifier: 10603295223481
• UDI-Public: 10603295223481
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K062654
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 94-0024
• Device Catalogue Number: 940024
• Device Lot Number: J29T38
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/27/2020
• Supplement Date Received by Manufacturer: 03/24/2020
• Initial Report FDA Received Date: 02/25/2020
• Supplement Report FDA Received Date: 03/25/2020
• 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: PFC*SIGMA/OV/DOME PAT 3PEG,38; SIG C/R POROCOAT FEM RT SZ 4; UNKNOWN KNEE TIBIAL INSERT
• Patient Age: 53 YR
• Patient Weight: 95