MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PFC*SIGMA TC3 FEM RT SZ3; SIGMA REVISION IMPLANT : KNEE FEMORAL

Catalog Number	960088
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	05/01/2024
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
Revision of tc3 due to significant instability.Malpositioning of the implants contributed to this during the initial case.Initial surgery date unknown.
Event or Problem Description
Additional information received: please confirm what implants were mispositioned.¿ femoral component and tibial tray.Was instability related to polyethylene wear? no, due to the mispositioning of the implants.Was there any reported malposition of components that led to the instability? no were any components undersized on the primary surgery that led to the instability? no, all correct sizing.Was the femur or tibia excessively resected/joint line raised during the primary surgery that led to the instability? no, reported as okay.Was there a surgical delay because of this event? if yes, what is the duration of the delay? no.
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: revision of tc3 due to significant instability.Malpositioning of the implants contributed to this during the initial case.The product was not returned to depuy synthes, however photos were provided for review.See attachment (revision 1 may.Jpg and revision 1 may 2.Jpg).The photo investigation revealed the pfc*sigma tc3 fem rt sz3 can be seen with what appears to be cement debris still attached to the inner surface, from the photo provided is not possible to properly identify if there is any interdigitation.It is worth noting that the middle inner rim (where the bolt and adaptor assemble with he femoral component) is damaged but due to the quality of the photograph is not possible to determine if it was caused by the extraction process or other device interaction.With information provided a potential cause cannot be established.However, consideration must be given to all other potential causes such as surgical process, patient variables and/or extraction procedure.Since the device was not returned, a dimensional inspection cannot be performed.The overall complaint was not confirmed as the observed condition of the pfc*sigma tc3 fem rt sz3 would not contribute to the complained device issue.Based on the investigation findings, 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 hm7737 and no non-conformances or manufacturing irregularities were identified.

• Common Device Name: SIGMA REVISION IMPLANT : KNEE FEMORAL
• 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: 19261604
• Report Number: 1818910-2024-10045
• Device Sequence Number: 15082859
• Product Code: JWH
• UDI-Device Identifier: 10603295232551
• UDI-Public: 10603295232551
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: K952830
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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,Followup
• Report Date (Section B): 05/07/2024

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: 11/30/2022
• Device Catalogue Number: 960088
• Device Lot Number: HM7737
• 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: 05/01/2024
• Supplement Date Received by Manufacturer: 05/13/2024; 06/20/2024
• Initial Report FDA Received Date: 05/07/2024
• Supplement Report FDA Received Date: 05/14/2024; 06/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/20/2017
• 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 TRAY SLEEVE POR M/L 45MM.; MBT TRAY SLEEVE POR M/L 45MM.; PFC SIGMA FEM POST AUG SZ3 4MM.; SIGMA FEM ADAPTER 5 DEGREE.; SIGMA FEM ADAPTER NEUTRAL BOLT.; TC3 RP TIBIAL INSERT S3,17.5.; UNIVERSAL FEM SLV DIS POR 34MM.; UNIVERSAL STEM 75X12MM FLUTED.; UNIVERSAL STEM 75X12MM FLUTED.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown