MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PFC*SIGMA C/R NPOR FEM LT SZ5; SIGMA KNEE PRIMARY : KNEE FEMORAL

Model Number	96-0005
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Fall (1848); Pain (1994); Joint Laxity (4526)
Date of Event	10/28/2013
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
Procedure: revision total knee replacement.Original surgery was in (b)(6) 2009.These implants were revised on (b)(6) 2013 as the patient had a fall and caused some mid flexion instability and was not happy with the function of his knee.This revision surgery was not due to fault of our implants but due to trauma and subsequent mid flexion instability.Subsequent additional information received indicated the patient had reports of pain.There are no pre op or post op xrays.The explants were discarded.Doi: (b)(6) 2009; dor: (b)(6) 2013; left knee.
Event or Problem Description
Additional information received indicated that the patient was revised for complaints of pain with suspected infection, not being confirmed intraoperatively.
Additional Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.H10 additional narrative:  if information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Corrected: g1, h6 (clinical code).Code for infection was removed, since infection was not being confirmed intraoperatively.
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 KNEE PRIMARY : KNEE FEMORAL
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 12180182
• Report Number: 1818910-2021-15361
• Device Sequence Number: 911232
• Product Code: JWH
• UDI-Device Identifier: 10603295231974
• UDI-Public: 10603295231974
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K943462
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Device Explanted Year: 2013
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/28/2013

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: 96-0005
• Device Catalogue Number: 960005
• Device Lot Number: 2294306
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/25/2021
• Supplement Date Received by Manufacturer: 06/25/2021; 09/01/2021
• Initial Report FDA Received Date: 07/16/2021
• Supplement Report FDA Received Date: 07/20/2021; 09/01/2021
• 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: DEPUY CMW 2G 20G; DEPUY CMW 2G 40G; MBT REVISION CEM TIB TRAY SZ 5; MBT TRAY SLEEVE POR M/L 53MM; PFC SIGMARP CV TB/IN S5 17.5; PFC*SIGMA C/R NPOR FEM LT SZ5; PFC*SIGMA/OV/DOME PAT 3PEG,41; DEPUY CMW 2G 20G; DEPUY CMW 2G 40G; MBT REVISION CEM TIB TRAY SZ 5; MBT TRAY SLEEVE POR M/L 53MM; PFC SIGMARP CV TB/IN S5 17.5; PFC*SIGMA C/R NPOR FEM LT SZ5; PFC*SIGMA/OV/DOME PAT 3PEG,41
• Outcome Attributed to Adverse Event: Required Intervention