MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US TC3 RP TIBIAL INSERT S3,12.5; SIGMA REVISION IMPLANT : KNEE TIBIAL INSERT

Catalog Number	962342
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/26/2023
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
Knee replacement tc3 surgery 8 years ago (2015) with stem and sleeves both tibia and femur.Adapter and bolt is broken.Femur had no contact.Sleeve very well fixated.Clinical outcome experienced by the patient, extraction of the implants, surgery with spacer and planned for lps revision.Additional event information: it was found during the visual examination performed on 22nov2023 that the tibial insert is damaged/worn.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : knee replacement tc3 surgery 8 years ago with stem and sleeves both tibia and femur.Adapter and bolt is broken.Femur had no contact.Sleeve very well fixated.The product was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device.Visual analysis of the returned sample revealed that the [tc3 rp tibial insert s3,12.5] was worn out from 1 of the condyles area.The mode of failure of the device is multi-factorial and consideration must be given to all other potential influences such as surgical process, patient variables (e.G.Activity level and use), anatomical considerations and patient changes over time.Any conclusions from the investigational input provided have to be placed into context with all other relevant factors.A dimensional inspection was not performed since it was not applicable to the complaint condition.The overall complaint was confirmed as the observed condition of the [tc3 rp tibial insert s3,12.5] would not contribute to the complained device issue.  based on the investigation findings, the potential cause cannot be established, 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 reported 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 : a manufacturing record evaluation was performed for the finished device product code: 962342 product description: tc3 rp tibial insert s3,12.5 lot# 686949 and no non-conformances or manufacturing irregularities were identified.

• Brand Name: TC3 RP TIBIAL INSERT S3,12.5
• 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): JTE WARSAW MFG SITE; 700 orthopaedic drive; warsaw IN
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 18226963
• Report Number: 1818910-2023-24199
• Device Sequence Number: 6211856
• Product Code: NJL
• UDI-Device Identifier: 10603295242222
• UDI-Public: 10603295242222
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: P830055
• 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
• Report Date (Section B): 11/29/2023

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2020
• Device Catalogue Number: 962342
• Device Lot Number: 686949
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/22/2023
• Supplement Date Received by Manufacturer: 12/11/2023
• Initial Report FDA Received Date: 11/29/2023
• Supplement Report FDA Received Date: 12/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/20/2015
• 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 SZ 3; MBT TRAY SLEEVE POR M/L 45MM; S-ROM*SLEEVE PRX ZTT, 20D-SML; SIGMA FEM ADAPTER 5 DEGREE; SIGMA FEM ADAPTER NEUTRAL BOLT; UNIVERSAL FEM SLV DIS POR 40MM; UNIVERSAL STEM 75X12MM FLUTED; UNIVERSAL STEM 75X16MM FLUTED; UNK COMPETITOR CEMENT; UNK KNEE FEMORAL SIGMA; UNK PATELLA TRIAL; UNKNOWN KNEE FEMORAL STEM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown