MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PFC*SIGMA C/R NPOR FEM LT SZ 4; SIGMA KNEE PRIMARY : KNEE FEMORAL

Model Number	96-0004
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Discomfort (2330); Osteolysis (2377); Ambulation or Postural Difficulties (2544); Joint Laxity (4526); Swelling/ Edema (4577)
Date of Event	01/26/2021
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
Study: (b)(6).Clinical notification received for revision of left total knee to address femoral osteolysis.Date of implantation: (b)(6) 2019, date of revision: (b)(6) 2021, (left knee).Treatment: femur and tibial insert revised.Additional information received: on (b)(6) 2019, the patient underwent a primary left knee arthroplasty due to osteoarthritis.Depuy products were implanted.On (b)(6) 2021, the patient underwent a left knee revision to address pain, discomfort, edema, instability, walking difficulty, and osteolysis.Pre-operatively the surgeon suspected femoral component was loose, however, the revision operative note confirmed the femoral component was well-fixed.The surgeon noted minimal bone loss to the femur.The tibial insert and femoral component were revised.The tibial tray and patellar component were retained.There were no indicated intra-operative complications.
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.

• 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: 11371973
• Report Number: 1818910-2021-03717
• Device Sequence Number: 13686658
• Product Code: JWH
• UDI-Device Identifier: 10603295231967
• UDI-Public: 10603295231967
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K943462
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• 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
• Report Date (Section B): 02/10/2021

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: 96-0004
• Device Catalogue Number: 960004
• Device Lot Number: D19012710
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/10/2021
• Supplement Date Received by Manufacturer: 03/30/2021
• Initial Report FDA Received Date: 02/24/2021
• Supplement Report FDA Received Date: 04/01/2021
• 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: DEPUY CMW 1 40G; DEPUY CMW 1 40G; MBT CEM KEEL TIB TRAY SZ4; PFC*SIGMA/OV/DOME PAT 3PEG,38; SIG RP AOX CRV INS SZ4 12.5; DEPUY CMW 1 40G; DEPUY CMW 1 40G; MBT CEM KEEL TIB TRAY SZ4; PFC*SIGMA/OV/DOME PAT 3PEG,38; SIG RP AOX CRV INS SZ4 12.5
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 74 YR
• Patient Weight: 82