MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PFC*SIGMA TC3 FEM RT SZ4; SIGMA REVISION IMPLANT : KNEE FEMORAL

Model Number	96-0089
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	05/25/2021
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
It was reported that the patient had a total implant explanted, convert to antibiotic spacer due to infection.Poly insert changed on (b)(6) 2019 from previous infection.Doi: (b)(6) 2019 all explanted products, doi: (b)(6) 2019 tibial insert, 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.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.Device history lot: a search of the depuy nonconformance (nc) quality system found no nc¿s associated with this product/lot combination.Based on the inability to find any nc¿s against the provided product code/lot code combination, it is reasonable to conclude that there are no anomalies with regard to manufacturing or inspection contained in the device history records that would contribute to the reported event.

• 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: 11917881
• Report Number: 1818910-2021-11510
• Device Sequence Number: 3179284
• Product Code: JWH
• UDI-Device Identifier: 10603295232568
• UDI-Public: 10603295232568
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K952830
• 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: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/25/2021

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: 96-0089
• Device Catalogue Number: 960089
• Device Lot Number: HG7485
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/25/2021
• Supplement Date Received by Manufacturer: 07/23/2021
• Initial Report FDA Received Date: 06/01/2021
• Supplement Report FDA Received Date: 07/23/2021
• 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 REV TIB TRAY SIZE 3 25MM; PFC SIGMA FEM POST AUG SZ4 4MM; PFC SIGMA FEM POST AUG SZ4 4MM; PFC*SIGMA DIS AUG 4MM,SZ4,RGHT; PFC*SIGMA DIS AUG 4MM,SZ4,RGHT; PFC*SIGMA TC3 FEM RT SZ4; PFC*SIGMA/RD/DOME PAT 3PEG,38; SIG FEM ADAP +2/-2 OFFSET BOLT; SIGMA FEM ADAPTER 5 DEGREE; SMARTSET MV 40G - EO; SMARTSET MV 40G - EO; TC3 RP TIBIAL INSERT S4,30.0; UNIVERSAL FEM SLV FUL POR 46MM; UNIVERSAL STEM 150X22MM FLUTED; MBT REV TIB TRAY SIZE 3 25MM.; PFC SIGMA DIS AUG 4MM,SZ4,RGHT.; PFC SIGMA DIS AUG 4MM,SZ4,RGHT.; PFC SIGMA FEM POST AUG SZ4 4MM.; PFC SIGMA FEM POST AUG SZ4 4MM.; PFC SIGMA TC3 FEM RT SZ4.; PFC SIGMA/RD/DOME PAT 3PEG,38.; SIG FEM ADAP +2/-2 OFFSET BOLT.; SIGMA FEM ADAPTER 5 DEGREE.; SMARTSET MV 40G - EO.; SMARTSET MV 40G - EO.; TC3 RP TIBIAL INSERT S4,30.0.; UNIVERSAL FEM SLV FUL POR 46MM.; UNIVERSAL STEM 150X22MM FLUTED.
• Outcome Attributed to Adverse Event: Required Intervention