MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US MBT CEM TIBIAL TRAY SZ5; MBT TIBIAL TRAY : KNEE TIBIAL TRAY

Catalog Number	129431150
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	01/30/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision of an lcs knee done in [year].Left.Reason for revision was due to instability.Femur and tibia were not loose and were well fixed.All components were removed, and attune revision with s-rom noiles was implanted.Lot number of the insert was not showing up when i searched for it.See attached pic.Unable to confirm the lot or ref number of the femoral component.Ref number will either be 129402060 or 129412060.Patient status/ outcome / consequences : was other medical intervention (e.G.X-rays, additional procedures, prescriptions, otc, revision) required: : unknown, is the patient part of a clinical study : unknown, (b)(6).Device property of : none, device in possession of : none, (b)(6).Device property of : none, device in possession of : none.By checking this box i certify that all information that are known/available has been disclosed.If any new information will be made available, the additional information will be submitted through cst: true.
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.
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, that 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.
Event or Problem Description
Additional information was received.E.Was instability related to polyethylene wear? no, poly wear was noted.F.Was there any reported malposition of components that led to the instability? no.G.Were any components undersized on the primary surgery that led to the instability? no.H.Was the femur or tibia excessively resected/joint line raised, during the primary surgery that led to the instability? no.Instability was, due to insufficient supporting ligaments.Therefore, needed constraint from srom noiles.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : revision of an lcs knee done in [year].Left.Reason for revision was due to instability.Femur and tibia were not loose and were well fixed.All components were removed, and attune revision with s-rom noiles was implanted.The product was not returned to depuy synthes, however photos were provided for review.Visual analysis of the photos revealed that mbt cem tibial tray sz5 presents nothing indicative of a device nonconformance or defects that could have contributed to the reported event.The fixation surface of the device presents signs of what appears to be bone ingrowth and cement.As the device was not returned, an as-received condition could not be assessed, and a dimensional inspection and document/specification review were not completed.The overall complaint was not confirmed as the observed condition of the mbt cem tibial tray sz5 would not contribute to the complained event.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 : 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 manufacturing records evaluation (mre) was not performed.

• Brand Name: MBT CEM TIBIAL TRAY SZ5
• Common Device Name: MBT TIBIAL TRAY : KNEE TIBIAL TRAY
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY IRELAND 9616671OUSE; loughbeg, ringaskiddy co.; cork ; EI
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 18682694
• Report Number: 1818910-2024-02827
• Device Sequence Number: 12590056
• Product Code: NJL
• UDI-Device Identifier: 10603295025627
• UDI-Public: 10603295025627
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: P830055
• 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): 02/10/2024

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 09/21/2010
• Device Catalogue Number: 129431150
• Device Lot Number: 1969679
• 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: 01/30/2024
• Supplement Date Received by Manufacturer: 02/19/2024; 03/07/2024
• Initial Report FDA Received Date: 02/10/2024
• Supplement Report FDA Received Date: 02/20/2024; 03/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/21/2005
• 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: LCS COMP RP INSERT LG 10MM; UNKNOWN KNEE FEMORAL
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male