MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PFC*SIGMA C/S NPOR FEM RT SZ 3; SIGMA KNEE PRIMARY : KNEE FEMORAL

Model Number	96-0053
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Inflammation (1932); Pain (1994); No Code Available (3191)
Date of Event	02/10/2020
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
Surgeon reported that a patient, who has a total knee implanted 15 years ago, experienced some anterior knee pain, clunking related to possible patella issues.The patient also reported that there was an inflammation.He performed a revision, where it was discovered that the patella had some wear and had become misshapen.The patella had a groove worked into it.It could have been from a fall, according to the surgeon.Otherwise, the rest of the total knee looked good.He replaced the liner, checked that all the components were well fixed and replaced the patella button with a new one.Original surgery was (b)(6) 2005.
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.Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.A worldwide complaint database search found no other related reported incidents against the provided product code/lot number combination since release for distribution.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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch, a follow-up medwatch will be filed as appropriate.

• 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: 9750827
• Report Number: 1818910-2020-05920
• Device Sequence Number: 16861862
• Product Code: JWH
• UDI-Device Identifier: 10603295232360
• UDI-Public: 10603295232360
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K950010
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2005
• Reporter Type: Manufacturer
• Report Source: foreign
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/10/2020

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: 96-0053
• Device Catalogue Number: 960053
• Device Lot Number: HX51753B
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/10/2020
• Supplement Date Received by Manufacturer: 04/27/2020
• Initial Report FDA Received Date: 02/25/2020
• Supplement Report FDA Received Date: 04/28/2020
• 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 KEEL TIB TRAY CEM SZ3; PFC SIGMA OVAL/DOME PATELLA 3PEG 32MM; PFC SIGMA STAB INS SZ3 12.5MM
• Outcome Attributed to Adverse Event: Required Intervention