MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 MBT CEM KEEL TIB TRAY SZ2.5; MBT TIBIAL TRAY : KNEE TIBIAL TRAY

Catalog Number	129433125
Medical Device Problem Code	Loss of or Failure to Bond (1068)
Health Effect - Clinical Codes	Fall (1848); Pain (1994)
Date of Event	04/30/2024
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
Patient had a right total knee done on (b)(6) 2016.Patient fell recently.Exhibited knee pain.X-rays showed possible loose tibia.Cemented tibia was loose.There was no cement adhering to the tibial plate.Cement was stuck on the tibial plateau and in the canal.Was the loosening of the implant caused by the fall or original cement used.We were unable to determine what type of cement was used.The hospital logs do not go back that far to verify it.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: patient had a right total knee done on (b)(6) 2016.Pt fell recently.Exhibited knee pain.X-rays showed possible loose tibia.Cemented tibia was loose.There was no cement adhering to the tibial plate.Cement was stuck on the tibial plateau and in the canal.Was the loosening of the implant caused by the fall or original cement used.We were unable to determine what type of cement was used.The hospital logs do not go back that far to verify it.The product was not returned to depuy synthes, however photos were provided for review.See attachment (der paulette godwin.Pdf).The x-ray investigation revealed nothing indicative of a device nonconformance.With evidence provided, the reported condition cannot be confirmed.A dimensional inspection was not performed since it was not applicable to the complaint condition.A functional test was not performed since it was not applicable to the complaint condition.The overall complaint was not confirmed as the observed condition of the mbt cem keel tib tray sz2.5 would not contribute to the complained device issue.Based on the investigation findings, the potential cause was not 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 8346142 number, and no non-conformances nor manufacturing irregularities were identified.Device history review : a manufacturing record evaluation was performed for the finished device 8346142 number, and no non-conformances nor manufacturing irregularities were identified.

• Brand Name: MBT CEM KEEL TIB TRAY SZ2.5
• Common Device Name: MBT TIBIAL TRAY : KNEE TIBIAL TRAY
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): CORK MFG & MATERIAL WAREHOUSE; loughbeg ringaskiddy; cork ; EI
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 19305628
• Report Number: 1818910-2024-10509
• Device Sequence Number: 6728482
• Product Code: NJL
• UDI-Device Identifier: 10603295076445
• UDI-Public: (01)10603295076445(17)200630(10)8156929
• 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: 2016
• Device Explanted Year: 2024
• 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): 05/13/2024

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: 06/30/2021
• Device Catalogue Number: 129433125
• Device Lot Number: 8346142
• 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: 04/30/2024
• Supplement Date Received by Manufacturer: 08/22/2024
• Initial Report FDA Received Date: 05/13/2024
• Supplement Report FDA Received Date: 08/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/14/2016
• 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
• Concomitant Medical Products and Therapy/Usage Dates: HP STRL QUICK DRL PINS.; HP STRL THREADED PINS HEADED.; PFC*SIGMA/RD/DOME PAT 3PEG,32.; SIG RP AOX STB INS SZ2.5 10.; SIGMA PS CEM FEM SZ2.5 R.; UNK CEMENT.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 57 YR
• Patient Sex: Female