MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PFC*SIGMA TC3 FEM LEFT SZ5; SIGMA REVISION IMPLANT : KNEE FEMORAL

Model Number	96-0084
Medical Device Problem Code	Noise, Audible (3273)
Health Effect - Clinical Codes	Pain (1994); Joint Laxity (4526); Swelling/ Edema (4577)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint #: (b)(4).Initial reporter: litigation letter.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
Office notes (b)(6) 201 - (b)(6) 2019 indicate the patient is experiencing swelling, popping, instability and pain of the left knee.He is also experiencing swelling, pain, numbness and instability in the right knee and feelings of crunching and cracking.Current treatment includes oral pain medication, physical therapy, knee braces and nerve blocks.No evidence of additional revision of products.Doi: (b)(6) 2018 (tray - captured in (b)(4)), doi: (b)(6) 2019 (femur, patella and insert - captured in (b)(4)), dor: none reported, left 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.

• Common Device Name: SIGMA REVISION IMPLANT : KNEE FEMORAL
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 11723851
• Report Number: 1818910-2021-08652
• Device Sequence Number: 17130274
• Product Code: JWH
• UDI-Device Identifier: 10603295232513
• UDI-Public: 10603295232513
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K952830
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted 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): 03/31/2021

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 96-0084
• Device Catalogue Number: 960084
• Device Lot Number: J0172H
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/31/2021
• Supplement Date Received by Manufacturer: 06/30/2021
• Initial Report FDA Received Date: 04/26/2021
• Supplement Report FDA Received Date: 07/01/2021
• 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: BIOMET REFOBACIN BONE CEMENT; BIOMET REFOBACIN BONE CEMENT; MBT REVISION CEM TIB TRAY SZ 4; PFC*SIGMA TC3 FEM LEFT SZ5; PFC*SIGMA/OV/DOME PAT 3PEG,41; TC3 RP TIBIAL INSERT S5,17.5; BIOMET REFOBACIN BONE CEMENT; BIOMET REFOBACIN BONE CEMENT; MBT REVISION CEM TIB TRAY SZ 4; PFC*SIGMA TC3 FEM LEFT SZ5; PFC*SIGMA/OV/DOME PAT 3PEG,41; TC3 RP TIBIAL INSERT S5,17.5
• Outcome Attributed to Adverse Event: Required Intervention