MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PFC SIG CR NPOR FEM LT SZ 4N; SIGMA KNEE PRIMARY : KNEE FEMORAL

Model Number	1960-00-400
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	02/06/2020
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: prosthesis implanted with constrained to promote stability.Original oxford unicompartmental knee (zimmer biomet) revised to pfc tkr using primary cr femoral component and cr rp curved bearing.Tibia mbt revision tibia and step wedge and stem to counter for bone loss associated with the oxford unicompartmental knee.Patella resurfaced at time of surgery to a pfc oval dome patella which remains in situ.The patient experiencing instability and femoral component and bearing revised to a pfc tc3 rp femoral component and tc3 rp bearing to promote stability.
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.H10 additional 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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: PFC SIG CR NPOR FEM LT SZ 4N
• 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: 9742019
• Report Number: 1818910-2020-05734
• Device Sequence Number: 18921247
• Product Code: JWH
• UDI-Device Identifier: 10603295074762
• UDI-Public: 10603295074762
• 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: 2019
• 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): 02/06/2020

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: 1960-00-400
• Device Catalogue Number: 196000400
• Device Lot Number: HX2863
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/06/2020
• Supplement Date Received by Manufacturer: 03/20/2020
• Initial Report FDA Received Date: 02/21/2020
• Supplement Report FDA Received Date: 03/24/2020
• 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: MBT REVISION CEM TIB TRAY SZ 3; PFC SIGMARP CV TB/IN S4 10.0; PFC*SIGMA/OV/DOME PAT 3PEG,38; UNIVERSAL STEM 75X20MM FLUTED
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 75 YR