MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PFC SIGMARP STB TB IN 4 22.5; SIGMA KNEE PRIMARY : KNEE TIBIAL INSERT

Model Number	96-2146
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	05/03/2021
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
The patient was revised to address instability.He had his knee replaced some time ago by another surgeon and has had 6 revision surgeries after his original tka.The original implant date is unknown.It was reported that the surgeon does not know the specifics on what surgeon revised the patient's knee or exactly when the revisions took place.The patient came in to see the surgeon for instability and the decision was made by the surgeon and the patient to revise the knee.During the revision, the sigma sz 4 ps femur and sz 4 x 22.5 rp insert were explanted.The patella and the tibial tray were left in situ.A new femoral component with stem, augments and sleeve were implanted along with a new bearing.Doi: unknown, dor: (b)(6) 2021, 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: PFC SIGMARP STB TB IN 4 22.5
• 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: 11818947
• Report Number: 1818910-2021-10182
• Device Sequence Number: 3149159
• Product Code: NJL
• UDI-Device Identifier: 10603295241362
• UDI-Public: 10603295241362
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/03/2021

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: 96-2146
• Device Catalogue Number: 962146
• Device Lot Number: 7910948
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/03/2021
• Supplement Date Received by Manufacturer: 06/29/2021
• Initial Report FDA Received Date: 05/13/2021
• Supplement Report FDA Received Date: 06/29/2021
• 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: PFC*SIGMA C/S NPOR FEM RT SZ 4; UNKNOWN KNEE PATELLA; UNKNOWN KNEE TIBIAL TRAY; PFC*SIGMA C/S NPOR FEM RT SZ 4; UNKNOWN KNEE PATELLA; UNKNOWN KNEE TIBIAL TRAY
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 76 YR