MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 PFC SIGMARP STB TB IN 5 12.5; SIGMA KNEE PRIMARY : KNEE TIBIAL INSERT

Model Number	96-2152
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); No Code Available (3191)
Date of Event	10/15/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Initial reporter occupation: lawyer.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 2nd right knee revision for a polyethylene swap due to instability and pain.The surgeon indicated debridement was performed of extensive tissue in the medial side of the joint due to medial laxity.The patient was implanted with the patient implanted with depuy knee system.Competitor¿s cement was utilized, and there were no complications reported.Product information can be found on page 14/19 of the attached medical records.Doi: (b)(6) 2015 (patella); doi: (b)(6) 2016 (all other implants); dor: (b)(6) 2018 (right knee).
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.H10 additional narrative: corrected: h6.Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.Depuy synthes considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.Device history lot: null.Device history batch: null.Device history review: null.If information is obtained that was not available for the initial medwatch, a follow-up medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: PFC SIGMARP STB TB IN 5 12.5
• Common Device Name: SIGMA KNEE PRIMARY : KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 9519746
• Report Number: 1818910-2019-124635
• Device Sequence Number: 516447
• Product Code: NJL
• UDI-Device Identifier: 10603295241393
• UDI-Public: 10603295241393
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/04/2019

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 Model Number: 96-2152
• Device Catalogue Number: 962152
• Device Lot Number: 8262610
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/04/2019
• Supplement Date Received by Manufacturer: 01/22/2020
• Initial Report FDA Received Date: 12/26/2019
• Supplement Report FDA Received Date: 01/23/2020
• 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: ATTUNE MEDIAL DOME PAT 41MM; MBT REVISION CEM TIB TRAY SZ 5; MBT TRAY SLEEVE POR M/L 45MM; SIG FEM ADAP +2/-2 OFFSET BOLT; SIGMA FEM ADAPTER 5 DEGREE; SIGMA PS CEM FEM SZ5 R; SMARTSET GHV GENTAMICIN 40G; UNIVERSAL STEM 75X18MM FLUTED; UNIVERSAL STEM 75X22MM FLUTED
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 55 YR