MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SIG RP AOX CRV INS SZ5 12.5; SIGMA KNEE PRIMARY : KNEE TIBIAL INSERT

Catalog Number	196192052
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Fall (1848); Unspecified Infection (1930); Pain (1994); Swelling (2091); Osteolysis (2377); No Code Available (3191)
Date of Event	08/05/2019
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)(6).Dots.Clinical adverse event received for hemarthrosis and suspected loosening, there is lytic area in femur zone 1, question of infection as well.Event is serious and is considered moderate.Event is definitely related to device and there is a remote possibility related to procedure.Date of implantation: (b)(6) 2019.Date of event: (b)(6) 2019.(left knee).Treatment: left knee revised to address infection, with removal of all implants, and placement of an antibiotic spacer.Depuy components: catalog id: 960103, lot: 8966832, description: sigma patella oval dome 3 pegged 41mm; catalog id: 129433150, lot: 8979680, description: mbt cemented keel sz 5; catalog id: 196192052, lot: 8956325, description: aox cvd rp tibial insert sz 5 12.5mm ; catalog id: 960005, lot: 9030602, description: sigma fem c/ret cemented lt sz 5; catalog id: 3332040, lot: 8835332, description: smart set bone cement cmw3 ; catalog id: 3332040, lot: 8835332, description: smart set bone cement cmw3;.
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Additional Manufacturer Narrative
Product complaint (b)(4).Depuy synthes is submitting this report pursuant to the provision depuy synthes of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.H10 additional narrative: 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: SIG RP AOX CRV INS SZ5 12.5
• 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: 9202743
• Report Number: 1818910-2019-110405
• Device Sequence Number: 16901863
• Product Code: NJL
• UDI-Device Identifier: 10603295076254
• UDI-Public: 10603295076254
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional,study
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/25/2019

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 Catalogue Number: 196192052
• Device Lot Number: 8956325
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/25/2019
• Supplement Date Received by Manufacturer: 10/18/2019; 11/22/2019
• Initial Report FDA Received Date: 10/17/2019
• Supplement Report FDA Received Date: 10/28/2019; 11/22/2019
• 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: 63 YR
• Patient Weight: 132