MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS SIGMA PS CEM FEM SZ2.5 R; SIGMA KNEE PRIMARY : KNEE FEMORAL

Model Number	1960-50-250
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Synovitis (2094)
Date of Event	12/14/2020
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
The patient was revised to address pain and poly wear-induced synovitis.The patient's primary sigma fb rp knee components were removed and replaced by attune revision components.Doi: (b)(6) 2009, dor: (b)(6) 2020, right knee.
Additional Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.H10 additional narrative: added: d9.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: the received device was forwarded to commercialized product development for evaluation.Review of the received device was unable to confirm the reported events.The investigation found no evidence of product malfunction or product error and the need for corrective action was not established.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.Corrected: h3.

• Brand Name: SIGMA PS CEM FEM SZ2.5 R
• Common Device Name: SIGMA KNEE PRIMARY : KNEE FEMORAL
• Manufacturer (Section D): DEPUY ORTHOPAEDICS; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 11093189
• Report Number: 1818910-2020-27855
• Device Sequence Number: 10987095
• Product Code: JWH
• UDI-Device Identifier: 10603295075127
• UDI-Public: 10603295075127
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/14/2020

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: 1960-50-250
• Device Catalogue Number: 196050250
• Device Lot Number: DF9L94
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/30/2020
• Initial Date Received by Manufacturer: 12/14/2020
• Supplement Date Received by Manufacturer: 12/30/2020; 02/11/2021
• Initial Report FDA Received Date: 12/30/2020
• Supplement Report FDA Received Date: 01/12/2021; 02/11/2021
• 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: MBT CEM KEEL TIB TRAY SZ2; PFC SIGMARP STB TB IN 2.5 10.0; PFC*SIGMA/RD/DOME PAT 3PEG,35; SMARTSET MEDIUM VISCOSITY BONE CEMENT; MBT CEM KEEL TIB TRAY SZ2; PFC SIGMARP STB TB IN 2.5 10.0; PFC*SIGMA/RD/DOME PAT 3PEG,35; SMARTSET MEDIUM VISCOSITY BONE CEMENT
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 68 YR