MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SIG C/R POROCOAT FEM RT SZ 3; SIGMA KNEE PRIMARY : KNEE FEMORAL

Model Number	94-0023
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); No Code Available (3191)
Date of Event	05/07/2020
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
Patient underwent primary total knee replacement on (b)(6) 2013 where a pfc sigma was utilized.Patient has reported that she never felt comfortable and that it was not long after the primary tkr that she began to experience anterior knee pain.X rays of the knee appear to be acceptable, the patella appears to be a patella baha.A decision was made to revise the components and implant an attune revision system.On opening the knee, all components appeared to be well fixed.The femoral and tibial components were removed and the patella left in situ.The tibia was distalized and the femur subsequently balanced by distalized and up sizing.
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.  if information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.A worldwide complaint database search found no other reported incident(s) against the provided product/lot combination(s) since release for distribution.Based on previous investigations this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications.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.Corrective action was not indicated.

• Brand Name: SIG C/R POROCOAT FEM RT SZ 3
• 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: 10075116
• Report Number: 1818910-2020-12343
• Device Sequence Number: 2848155
• Product Code: JWH
• UDI-Device Identifier: 10603295223474
• UDI-Public: 10603295223474
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K062654
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/07/2020

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: 94-0023
• Device Catalogue Number: 940023
• Device Lot Number: 316119
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/07/2020
• Supplement Date Received by Manufacturer: 05/07/2020; 06/17/2020
• Initial Report FDA Received Date: 05/20/2020
• Supplement Report FDA Received Date: 05/26/2020; 06/18/2020
• 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: PFC*SIGMA/OV DOME PAT 3 PEG,32; SIG MOD TIB TRAY CEM COCR 3; SIGMA CRVD XLK INS 3 8MM; SMARTSET GHV GENTAMICIN 40G; PFC*SIGMA/OV DOME PAT 3 PEG,32; SIG MOD TIB TRAY CEM COCR 3; SIGMA CRVD XLK INS 3 8MM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 67 YR