MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SIGMA PS CEM FEM SZ3 R; SIGMA KNEE PRIMARY : KNEE FEMORAL

Model Number	1960-50-300
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Adhesion(s) (1695); Pain (1994)
Date of Event	01/08/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint #: (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) 2012, the patient underwent a primary bilateral knee arthroplasty to address severe degenerative gonarthrosis and chondromalacia.The patella was resurfaced and depuy products were implanted with depuy cement x 1 for each knee.There were no indicated intra-operative complications.On (b)(6) 2019, the patient underwent a right knee revision to address pain and tibial tray subsidence.The surgeon noted removal of scar tissue.The tibial tray tibial insert, and femoral component were revised.The patellar component was retained.There were no indicated intra-operative complications.Doi: (b)(6) 2012.Dor: (b)(6) 2019.Right 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.Device history lot: the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.

• Brand Name: SIGMA PS CEM FEM SZ3 R
• 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: 12125940
• Report Number: 1818910-2021-14469
• Device Sequence Number: 11619862
• Product Code: JWH
• UDI-Device Identifier: 10603295075134
• UDI-Public: 10603295075134
• 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: 2012
• Device Explanted Year: 2019
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/17/2021

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: 01/10/2022
• Device Model Number: 1960-50-300
• Device Catalogue Number: 196050300
• Device Lot Number: 3408768
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/17/2021
• Supplement Date Received by Manufacturer: 08/05/2021
• Initial Report FDA Received Date: 07/06/2021
• Supplement Report FDA Received Date: 08/05/2021
• 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: DEPUY1 GENTAMICIN CEMENT 40G; MBT CEM KEEL TIB TRAY SZ2.5; PFC SIGMARP STB TB IN 3 22.5; PFC*SIGMA/OV DOME PAT 3 PEG,32; SIGMA PS CEM FEM SZ3 R; DEPUY1 GENTAMICIN CEMENT 40G; MBT CEM KEEL TIB TRAY SZ2.5; PFC SIGMARP STB TB IN 3 22.5; PFC*SIGMA/OV DOME PAT 3 PEG,32; SIGMA PS CEM FEM SZ3 R
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 52 YR