MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 PFC SIG CR NPOR FEM RT SZ 4N; SIGMA KNEE PRIMARY : KNEE FEMORAL

Model Number	1960-01-400
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Pain (1994); Joint Dislocation (2374); No Code Available (3191)
Date of Event	03/23/2018
Type of Reportable Event	Serious Injury
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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Concomitant medical products: unknown knee all-poly tibial tray component; pfc sig cr npor fem rt sz 4n knee femur component; pfc sigma/ov/dome pat 3peg,38 knee patella component; unknown bone cement.
Event or Problem Description
Subject: (b)(6).Clinical adverse event received for disruption of the arthrotomy repair, status post right total knee, with patellar subluxation.Event is not serious and is considered moderate.Event is definitely not related to device and definitely related to procedure.Treatment includes irrigation and debridement with lateral release and repair of medial arthrotomy.Doi: (b)(6) 2018; doe: 03/23/2018; (right knee).
Additional Manufacturer Narrative
Product complaint: (b)(4).
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.Depuy synthes considers the investigation closed.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 RT SZ 4N
• Common Device Name: SIGMA KNEE PRIMARY : KNEE FEMORAL
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork, munster ; EI
• MDR Report Key: 7898820
• Report Number: 1818910-2018-70092
• Device Sequence Number: 1395078
• Product Code: JWH
• UDI-Device Identifier: 10603295074779
• UDI-Public: 10603295074779
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K943462
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional,study
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/18/2018

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 Expiration Date: 04/30/2026
• Device Model Number: 1960-01-400
• Device Catalogue Number: 196001400
• Device Lot Number: C29591
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/18/2018
• Supplement Date Received by Manufacturer: 09/21/2018; 04/29/2020
• Initial Report FDA Received Date: 09/21/2018
• Supplement Report FDA Received Date: 09/26/2018; 04/29/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Weight: 108