MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PFC SIGMARP STB TB IN 3 15.0; SIGMA KNEE PRIMARY : KNEE TIBIAL INSERT

Model Number	96-2133
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Cellulitis (1768); Unspecified Infection (1930); Inflammation (1932); No Code Available (3191)
Date of Event	07/06/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).Initial reporter occupation: lawyer.(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) 2018, the patient underwent a stage 1 of a 2-stage revision with the implantation of a temporary antibiotic cement spacer and antibiotic beads, and debridement, due to infection, inflammation, and cellulitis.He noted unhealthy looking and almost purulent looking tissue which was cultured and debrided.The surgeon reported the removal of the tibial and femoral components, the revision of the patellar component, and the implantation of the antibiotic spacer and antibiotic beads.The surgeon reported partial avulsion of the patellar tendon as a complication.The patient was implanted with competitor spacer and smartset bone cement x 2.Doi: (b)(6) 2015: (patellar component and 2 bone cement).Doi: (b)(6) 2018 (tibial tray, insert, stem and femoral component).Dor: (b)(6) 2018 (rt knee).
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary = > no device associated with this report was received for examination.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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: PFC SIGMARP STB TB IN 3 15.0
• 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: 9418176
• Report Number: 1818910-2019-120969
• Device Sequence Number: 13881051
• Product Code: NJL
• UDI-Device Identifier: 10603295241263
• UDI-Public: 10603295241263
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/12/2019

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 Expiration Date: 09/30/2021
• Device Model Number: 96-2133
• Device Catalogue Number: 962133
• Device Lot Number: 8397769
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/12/2019
• Supplement Date Received by Manufacturer: 01/08/2020
• Initial Report FDA Received Date: 12/05/2019
• Supplement Report FDA Received Date: 01/21/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 68 YR