MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PFC SIGMA TC3 FEM LEFT SZ2; SIGMA REVISION IMPLANT : KNEE FEMORAL

Model Number	96-0081
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	10/19/2021
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 infection.No loosening reported.Doi: (b)(6) 2020; dor: (b)(6) 2021; left knee.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will 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 SIGMA TC3 FEM LEFT SZ2
• Common Device Name: SIGMA REVISION IMPLANT : KNEE FEMORAL
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY RAYNHAM, A DIV. OF DEPUY ORTHO 1219655; 325 paramount drive; raynham MA 02767 0988
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 12719404
• Report Number: 1818910-2021-23966
• Device Sequence Number: 17213872
• Product Code: JWH
• UDI-Device Identifier: 10603295232483
• UDI-Public: 10603295232483
• 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: 2020
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/19/2021

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: 96-0081
• Device Catalogue Number: 960081
• Device Lot Number: 734751
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/19/2021
• Supplement Date Received by Manufacturer: 12/06/2021
• Initial Report FDA Received Date: 10/29/2021
• Supplement Report FDA Received Date: 12/08/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/04/2016
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: MBT REVISION CEM TIB TRAY SZ 2.; MBT TRAY SLEEVE POR M/L 37MM.; PFC SIGMA FEM POST AUG SZ2 4MM.; PFC SIGMA TC3 FEM LEFT SZ2.; PFC*SIGMA DI AUG12MMCO,SZ2LEFT.; PFC*SIGMA DI AUG16MMCO,SZ2LEFT.; PFC*SIGMA/RD/DOME PAT 3PEG,32.; SIG FEM ADAP +2/-2 OFFSET BOLT.; SIGMA FEM ADAPTER 5 DEGREE.; TC3 RP TIBIAL INSERT S2,15.0.; UNIVERSAL FEM SLV FUL POR 31MM.; UNIVERSAL STEM 75X12MM FLUTED.; UNIVERSAL STEM 75X12MM FLUTED.; MBT REVISION CEM TIB TRAY SZ 2; MBT TRAY SLEEVE POR M/L 37MM; PFC SIGMA FEM POST AUG SZ2 4MM; PFC SIGMA TC3 FEM LEFT SZ2; PFC*SIGMA DI AUG12MMCO,SZ2LEFT; PFC*SIGMA DI AUG16MMCO,SZ2LEFT; PFC*SIGMA/RD/DOME PAT 3PEG,32; SIG FEM ADAP +2/-2 OFFSET BOLT; SIGMA FEM ADAPTER 5 DEGREE; TC3 RP TIBIAL INSERT S2,15.0; UNIVERSAL FEM SLV FUL POR 31MM; UNIVERSAL STEM 75X12MM FLUTED
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female