MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US TC3 RP TIBIAL INSERT S2.5,15.0; SIGMA REVISION IMPLANT : KNEE TIBIAL INSERT

Catalog Number	962333
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Loss of Range of Motion (2032); Unspecified Musculoskeletal problem (4535)
Date of Event	07/11/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that patient underwent a left knee revision due to bony ingrowth preventing extension of the knee.Surgeon removed the poly to clean out the bony ingrowth and replaced the poly with a smaller/cr poly.There was no surgical delay.
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 the information is unknown, not available or does not apply, the section/field of the form is left blank.Device was used for treatment, not diagnosis.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 : according to the information received, "patient had a sigma revision knee done on (b)(6) 2017 at sibley memorial hospital by a surgeon.The patient was seen recently by another surgeon.She was unable to extend her leg.Xrays were taken and she has bony ingrowth around the poly, distal femur, and proximal tibia.Surgeon removed the poly to clean out the bony ingrowth.Replaced the poly with a smaller/cr poly." the product was not returned to depuy synthes, however photos were provided for review.See attachment (trent der.Pdf).Visual inspection of the provided photographic evidence revealed there were no product problems observed with the device.Based on the provided evidence, the adverse event can be confirmed, however, there was not enough evidence that suggests the reported adverse event was due to a device non conformance.The overall complaint was confirmed as the observed condition of the tc3 rp tibial insert s2.5,15.0 would contribute to the complained device issue.Based on the investigation findings, and it has been determined that no corrective and/or preventative action is proposed.There is no indication that a design or manufacturing issue has caused the complaint condition.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot : the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A records evaluation (mre) was not performed.

• Brand Name: TC3 RP TIBIAL INSERT S2.5,15.0
• Common Device Name: SIGMA REVISION IMPLANT : KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer Contact: kate karberg ; 700 orthpaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 17378138
• Report Number: 1818910-2023-14963
• Device Sequence Number: 6399307
• Product Code: NJL
• UDI-Device Identifier: 10603295242147
• UDI-Public: 10603295242147
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/24/2023

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 Catalogue Number: 962333
• Device Lot Number: 395430
• 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: 07/12/2023
• Supplement Date Received by Manufacturer: 08/24/2023
• Initial Report FDA Received Date: 07/24/2023
• Supplement Report FDA Received Date: 08/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/25/2013
• 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: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: MBT REVISION CEM TIB TRAY S2.5; MBT TRAY SLEEVE POR M/L 29MM; PFC SIG FEM POST AUG SZ2.5 4MM; PFC SIG FEM POST AUG SZ2.5 4MM; PFC*SIGMA DIS AUG4MM,S2.5,LEFT; PFC*SIGMA TC3 FEM LEFT S2.5; SIG FEM ADAP +2/-2 OFFSET BOLT; SIGMA FEM ADAPTER 5 DEGREE; UNIVERSAL STEM 115X12MM FLUTED; UNIVERSAL STEM 115X12MM FLUTED
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 58 YR
• Patient Sex: Female