MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 SIGMA PS CEM FEM SZ3 L; SIGMA KNEE PRIMARY : KNEE FEMORAL

Catalog Number	196040300
Medical Device Problem Code	Loss of or Failure to Bond (1068)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	10/01/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint #(b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803 (and/or part 4, as applicable).This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes, or its employees that the report constitutes an admission that the product, depuy synthes, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Event or Problem Description
It was reported that pfc implants were revised due to suspected loosening at tibial surface.
Additional Manufacturer Narrative
Product complaint # (b)(4).Information was received indicating that the revision was performed to treat loosening of the tibial tray.The tibial insert, femoral component, and patella were removed to access the loosened tibial tray.Due to this, depuy synthes joint reconstruction considers the device on this report to be not reportable as there is no allegation of deficiency or patient harm, additional follow up is being conducted.Further updates will only be provided if additional information is received that changes the regulatory determination.

• Brand Name: SIGMA PS CEM FEM SZ3 L
• Common Device Name: SIGMA KNEE PRIMARY : KNEE FEMORAL
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): CORK MFG & MATERIAL WAREHOUSE; loughbeg ringaskiddy; cork ; EI
• Manufacturer Contact: kate karberg ; 700 orthpaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 20409617
• Report Number: 1818910-2024-21213
• Device Sequence Number: 20862757
• Product Code: JWH
• UDI-Device Identifier: 10603295075042
• UDI-Public: (01)10603295075042(17)200817(10)3189230
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup

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 Expiration Date: 08/17/2020
• Device Catalogue Number: 196040300
• Device Lot Number: 3189230
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/02/2024
• Supplement Date Received by Manufacturer: 10/10/2024
• Initial Report FDA Received Date: 10/09/2024
• Supplement Report FDA Received Date: 10/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/19/2010
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown