MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 SIG MOD TIB TRAY CEM COCR 2; SIGMA KNEE PRIMARY : KNEE TIBIAL INSERT

Model Number	1581-20-000
Medical Device Problem Code	Loss of or Failure to Bond (1068)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	10/12/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Initial reporter occupation: lawyer.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
The patient underwent a second revision of the right knee on (b)(6) 2017 secondary to suspected tibial loosening.Intraoperatively, the surgeon confirmed tibial loosening at the cement to implant interface.The femoral and patellar components were well-fixed.The surgeon decided to implant a different system, therefore had to revise the femoral component as well due to this.No intraoperative complications noted.Doi: (b)(6) 2016; dor: (b)(6) 2016 (tibial components); dor: (b)(6) 2017; right knee.
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.Additional narrative: product complaint # (b)(4).Investigation summary no device associated with this report was received for examination.A worldwide lot specific complaint database search, or device history record (dhr) review, was not possible because the required lot number was not provided.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.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.

• Brand Name: SIG MOD TIB TRAY CEM COCR 2
• Common Device Name: SIGMA KNEE PRIMARY : KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 9553923
• Report Number: 1818910-2020-00609
• Device Sequence Number: 19581596
• Product Code: JWH
• UDI-Device Identifier: 10603295063810
• UDI-Public: 10603295063810
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K032151
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/12/2019

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: 1581-20-000
• Device Catalogue Number: 158120000
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/12/2019
• Supplement Date Received by Manufacturer: 02/03/2020
• Initial Report FDA Received Date: 01/06/2020
• Supplement Report FDA Received Date: 02/04/2020
• 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 DIS AUG 8MM,SZ3,RGHT; PFC*SIGMA DIS AUG 8MM,SZ3,RGHT; SIGMA FEM ADAPTER 5 DEGREE; SIGMA FEM ADAPTER NEUTRAL BOLT; SIGMA PS CEM FEM SZ3 R; SIGMA PS CEM FEM SZ3 R; SIGMA STAB XLK INS 2 17.5MM; UNIVERSAL STEM 115X12MM FLUTED; UNIVERSAL STEM 115X12MM FLUTED
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 52 YR