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	09/08/2021
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's knee was revised due to infection and loosening of the femoral & tibial component at the bone to cement interface.Unknown cement was used.Removal of all implants due to cement couldn't see most numbers.Only able to obtain the numbers from femoral stem, tc3 rp insert and the thick tray.All other parts were covered by cement.No further information is available.Doi: (b)(6) 2015 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.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.

• 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: 12517246
• Report Number: 1818910-2021-20848
• Device Sequence Number: 17477352
• Product Code: JWH
• UDI-Device Identifier: 10603295232568
• UDI-Public: 10603295232568
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K952830
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• 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): 09/08/2021

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: 590320
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/08/2021
• Supplement Date Received by Manufacturer: 10/04/2021
• Initial Report FDA Received Date: 09/22/2021
• Supplement Report FDA Received Date: 10/06/2021
• 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: BONE CEMENT (MFG. AND PRODUCT NAME UNKNOWN); MBT REV TIB TRAY SIZE 4 25MM; PFC SIGMA FEM POST AUG SZ4 4MM; PFC SIGMA FEM POST AUG SZ4 4MM; PFC*SIGMA DIS AUG 8MM,SZ4,RGHT; PFC*SIGMA DIS AUG 8MM,SZ4,RGHT; PFC*SIGMA TC3 FEM RT SZ4; SIG FEM ADAP +2/-2 OFFSET BOLT; SIGMA FEM ADAPTER 5 DEGREE; TC3 RP TIBIAL INSERT S4,30.0; UNIVERSAL STEM 75X22MM FLUTED; BONE CEMENT (MFG. AND PRODUCT NAME UNKNOWN); MBT REV TIB TRAY SIZE 4 25MM; PFC SIGMA FEM POST AUG SZ4 4MM; PFC SIGMA FEM POST AUG SZ4 4MM; PFC*SIGMA DIS AUG 8MM,SZ4,RGHT; PFC*SIGMA DIS AUG 8MM,SZ4,RGHT; PFC*SIGMA TC3 FEM RT SZ4; SIG FEM ADAP +2/-2 OFFSET BOLT; SIGMA FEM ADAPTER 5 DEGREE; TC3 RP TIBIAL INSERT S4,30.0; UNIVERSAL STEM 75X22MM FLUTED
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 59 YR