MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PFC*SIGMA TC3 FEM RT SZ3; SIGMA REVISION IMPLANT : KNEE FEMORAL

Model Number	96-0088
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Joint Laxity (4526); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	03/11/2021
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
The patient was revised to address significant flexion contracture but instability in flexion.Tibial components removed along with femoral components and converted to distal femoral replacement on existing femoral sleeve and stem.No surgical delay reported.Doi: (b)(6) 2018; 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 : 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).Where the product and lot code was provided, 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: 11555042
• Report Number: 1818910-2021-05841
• Device Sequence Number: 11745500
• Product Code: JWH
• UDI-Device Identifier: 10603295232551
• UDI-Public: 10603295232551
• 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: 2018
• 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): 03/11/2021

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: 96-0088
• Device Catalogue Number: 960088
• Device Lot Number: HW5559
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/11/2021
• Supplement Date Received by Manufacturer: 05/06/2021
• Initial Report FDA Received Date: 03/23/2021
• Supplement Report FDA Received Date: 05/07/2021
• 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 15MM; MBT TRAY SLEEVE POR M/L 37MM; PFC SIGMA DIS AUG 8MM,SZ3,RGHT; PFC SIGMA DIS AUG 8MM,SZ3,RGHT; PFC SIGMA FEM POST AUG SZ3 4MM; PFC SIGMA TC3 FEM RT SZ3; SIG FEM ADAP +2/-2 OFFSET BOLT; SIGMA FEM ADAPTER 5 DEGREE; TC3 RP TIBIAL INSERT S3,17.5; UNIVERSAL STEM 75X14MM FLUTED; UNK DEPUY CEMENT; MBT REV TIB TRAY SIZE 3 15MM; MBT TRAY SLEEVE POR M/L 37MM; PFC SIGMA DIS AUG 8MM,SZ3,RGHT; PFC SIGMA DIS AUG 8MM,SZ3,RGHT; PFC SIGMA FEM POST AUG SZ3 4MM; PFC SIGMA TC3 FEM RT SZ3; SIG FEM ADAP +2/-2 OFFSET BOLT; SIGMA FEM ADAPTER 5 DEGREE; TC3 RP TIBIAL INSERT S3,17.5; UNIVERSAL STEM 75X14MM FLUTED; UNK DEPUY CEMENT
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 45 YR
• Patient Weight: 98