MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SIG C/R POROCOAT FEM RT SZ 2; SIGMA KNEE PRIMARY : KNEE FEMORAL

Model Number	94-0022
Medical Device Problem Code	Loss of Osseointegration (2408)
Health Effect - Clinical Codes	Pain (1994); Osteolysis (2377); Inadequate Osseointegration (2646); No Code Available (3191)
Date of Event	05/06/2020
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
Revision total knee replacement: the patient presented to the surgeon with a painful knee.Bone scan showed the femur and patella were loose.Infection markers all within normal range.When implants were removed there were signs of osteolysis behind the femoral component central to the anterior chamfer region.No obvious signs of osteolysis on the poly of the insert or patella.Photos taken of implants.Implants discarded.No ae reported.No delay in the surgery.
Additional Manufacturer Narrative
Product complaint (b)(4).Investigation summary: no device was received.Root cause undetermined.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.Device history lot dhr reviewed for lot by7ef1000; there were no anomalies or deviations found during the review.

• Brand Name: SIG C/R POROCOAT FEM RT SZ 2
• 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: 10075192
• Report Number: 1818910-2020-12344
• Device Sequence Number: 2848157
• Product Code: JWH
• UDI-Device Identifier: 10603295223467
• UDI-Public: 10603295223467
• 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 Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 94-0022
• Device Catalogue Number: 940022
• Device Lot Number: BY7EF1000
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/07/2020
• Supplement Date Received by Manufacturer: 07/31/2020
• Initial Report FDA Received Date: 05/20/2020
• Supplement Report FDA Received Date: 07/31/2020
• 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 2.5; SIGMA CRVD GVF INS 2.5 8MM; PFC*SIGMA/OV DOME PAT 3 PEG,32; SIG MOD TIB TRAY CEM COCR 2.5; SIGMA CRVD GVF INS 2.5 8MM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 76 YR