MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PFC* MOD PLUS TIBIAL TRAY SZ 3; SIGMA REVISION IMPLANT : KNEE TIBIAL TRAY

Model Number	86-0123
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/13/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the universal stem could not be mounted and fixed into the tibia.Since complete assembly was not possible, the tibia construct with wedges could not be implanted.The procedure completed with new implants, no patient harm nor significant delay reported.
Additional Manufacturer Narrative
(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).This report is being submitted pursuant to the provisions of 21 cfr, part 803.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 joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, 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.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary :the device associated with this report was returned to depuy synthes for evaluation.Visual examination found part of the plug broken and stuck on the most inner section of the assembly post of the tibial tray, which could have been a contributing factor making it not possible to a mating component to sit completely flushed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot : product description: pfc* mod plus tibial tray sz 3 product code: 860123 lot number: j89y12.1) quantity manufactured: (b)(4), 2) date of manufacture: 01/27/2021, 3) any anomalies or deviations identified in dhr: na, 4) expiry date: 2030-08-31, 5) ifu reference: 090200252.Device history review : 1) quantity manufactured: (b)(4).2) date of manufacture: 01/27/2021 3) any anomalies or deviations identified in dhr: na 4) expiry date: 2030-08-31 5) ifu reference: 090200252.

• Common Device Name: SIGMA REVISION IMPLANT : KNEE TIBIAL TRAY
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY RAYNHAM, A DIV. OF DEPUY ORTHO 1219655; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: kate karberg ; 700 orthpaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 15685304
• Report Number: 1818910-2022-21451
• Device Sequence Number: 6497125
• Product Code: JWH
• UDI-Device Identifier: 10603295215448
• UDI-Public: 10603295215448
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K923807
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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,Followup
• Report Date (Section B): 10/27/2022

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: 86-0123
• Device Catalogue Number: 860123
• Device Lot Number: J89Y12
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/13/2022
• Supplement Date Received by Manufacturer: 11/21/2022; 12/29/2022
• Initial Report FDA Received Date: 10/27/2022
• Supplement Report FDA Received Date: 11/22/2022; 12/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/16/2020
• 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