MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PFC SIGMARP CV TB/IN S4 15.0; SIGMA KNEE PRIMARY : KNEE TIBIAL INSERT

Model Number	96-2043
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Fall (1848); Hemorrhage/Blood Loss/Bleeding (1888); Pain (1994); Synovitis (2094); Joint Laxity (4526); Swelling/ Edema (4577)
Date of Event	05/18/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(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: 007-08360, study: dots.Clinical notification received for revision of left total knee to address instability date of implantation: (b)(6) 2013, date of revision: (b)(6) 2021, (left knee).Treatment: revision of the tibial insert component.
Event or Problem Description
On (b)(6)2013, the patient underwent bilateral knee arthroplasties to address osteoarthritis.The patella was resurfaced and depuy products were implanted bilaterally.There were no indicated intra-operative complications.On (b)(6) 2021, the patient underwent a left knee revision to address pain, swelling, and instability.The patient experienced a fall prior to experiencing instability.The surgeon indicated evidence of recurrent bleeds as there was hemosiderin stained synovitis which was resected.There was a little wear on the retained patella, but no delamination.There was meniscus around the patella that was excised.The tibial insert was the only product revised.The tibial insert, femoral component, and patellar component were retained.There were no indicated intra-operative complications.
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:  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 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: PFC SIGMARP CV TB/IN S4 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: 12010318
• Report Number: 1818910-2021-12818
• Device Sequence Number: 3304039
• Product Code: NJL
• UDI-Device Identifier: 10603295240839
• UDI-Public: 10603295240839
• 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: 2013
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• 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): 06/03/2021

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 Model Number: 96-2043
• Device Catalogue Number: 962043
• Device Lot Number: 3254406
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/03/2021
• Supplement Date Received by Manufacturer: 06/15/2021; 07/26/2021
• Initial Report FDA Received Date: 06/16/2021
• Supplement Report FDA Received Date: 07/15/2021; 07/27/2021
• 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 SZ4; PFC SIGMA C/R NPOR FEM LT SZ 4; PFC SIGMA/OV/DOME PAT 3PEG,38
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 75 YR
• Patient Weight: 91