MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PFC SIG MOD TIB TRAY CEM SZ2.5; SIGMA KNEE PRIMARY : KNEE TIBIAL TRAY

Model Number	86-6029
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/15/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Upon implantation, tibial insert was not completely flush laterally leaving space between the tibial tray and the insert.Operated knee is right.Surgeon decided to change insert size to 10mm but same issue was observed.Final decision was to implant size 10 even with the problem involved.Fear of insert dislocation and backside wear remains.
Additional Manufacturer Narrative
Product complaint # = > (b)(4).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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.Device history lot: a manufacturing record evaluation (nc search) was performed for the finished device 866029, lot d21110757, and no non-conformances / manufacturing irregularities were identified.

• Brand Name: PFC SIG MOD TIB TRAY CEM SZ2.5
• Common Device Name: SIGMA KNEE PRIMARY : KNEE TIBIAL TRAY
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): JJM (SUZHOU) LTD. 3006356043; no.299 changyang st; suzhou industrial park; suzhou jiangsu 21512 -6; CH 21512-6
• Manufacturer Contact: kate karberg ; 700 orthpaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 15065636
• Report Number: 1818910-2022-13542
• Device Sequence Number: 5699098
• Product Code: JWH
• UDI-Device Identifier: 10603295216834
• UDI-Public: 10603295216834
• Combination Product (Y/N): N
• Initial Reporter Country: JO
• PMA/510(K) Number: K952830
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• 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
• Report Date (Section B): 07/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 86-6029
• Device Catalogue Number: 866029
• Device Lot Number: D21110757
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/04/2022
• Supplement Date Received by Manufacturer: 08/25/2022
• Initial Report FDA Received Date: 07/20/2022
• Supplement Report FDA Received Date: 08/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/27/2021
• 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
• Patient Sex: Unknown