MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SIG RP AOX CRV INS SZ2.5 10; SIGMA KNEE PRIMARY : KNEE TIBIAL INSERT

Model Number	1961-92-021
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Adhesion(s) (1695)
Date of Event	07/07/2021
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
Associated study: rotating platform, rotating platform date of evaluation: 9/feb/2015 date of onset: (b)(6) 2021 operative side: left.Diagnosis: adhesions lt tka.Adverse event: adhesions.On (b)(6) 2021, the patient had a left hybrid total knee arthroplasty to address primary osteoarthritis, end-stage, left knee.Depuy components, including depuy patella and depuy cement x2 were used during this procedure.On (b)(6) 2021, the patient had a closed manipulation under anesthesia to address arthrofibrosis, status post left total knee arthroplasty.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.All available x-rays were reviewed, and no evidence of implant fracture, disassociation, or anything indicative of a device nonconformance was found.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: SIG RP AOX CRV INS SZ2.5 10
• 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: 12467343
• Report Number: 1818910-2021-20007
• Device Sequence Number: 11848789
• Product Code: NJL
• UDI-Device Identifier: 10603295076124
• UDI-Public: 10603295076124
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted 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): 08/05/2021

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: 1961-92-021
• Device Catalogue Number: 196192021
• Device Lot Number: 9735351
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/24/2021
• Supplement Date Received by Manufacturer: 09/21/2021
• Initial Report FDA Received Date: 09/14/2021
• Supplement Report FDA Received Date: 09/21/2021
• 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 2 20G; DEPUY CMW 2 20G; MBT CEM KEEL TIB TRAY SZ2.5; PFC*SIGMA/OV/DOME PAT 3PEG,35; SIG C/R POROCOAT FEM LT SZ 2.5; SIG RP AOX CRV INS SZ2.5 10; DEPUY CMW 2 20G; DEPUY CMW 2 20G; MBT CEM KEEL TIB TRAY SZ2.5; PFC*SIGMA/OV/DOME PAT 3PEG,35; SIG C/R POROCOAT FEM LT SZ 2.5; SIG RP AOX CRV INS SZ2.5 10
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 60 YR
• Patient Weight: 57