MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US 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	Bone Fracture(s) (1870); Unspecified Infection (1930)
Date of Event	01/01/2022
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
It was reported that the patient fell in 2022 and suffered a tibial fracture.This appears to have caused the tibial plateau to collapse over time.Patient required a revision surgery on (b)(6) 2024 at hospital, the tibia came off relatively easily, with no cement attached to the bottom of the tibia.The cement used is believed to be a competitor at the time.The femur was well fixed, however the frozen tissue came back as infected.So all implants were removed.Doi: (b)(6) 2019.Dor: (b)(6) 2024.Affected side: right knee.
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.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary = > it was reported that the patient fell in 2022 and suffered a tibial fracture.This appears to have cause the tibial plateau to collapse over time.Patient required a revision surgery on (b)(6) 2024 at hospital, the tibia came off relatively easily, with no cement attached to the bottom of the tibia.The cement used is believed to be a competitor at the time.This is the second sigma tibial base that we was removed in about 4 weeks.Both had no cement on the tibia, only on bony interface.The femur was well fixed, however the frozen tissue came back as infected.So all implants were removed.The product was not returned to depuy synthes, however photos were provided for review.See attachment (29_may_2024_09_21_11_19359.Eml).Visual analysis of the radiological images revealed that keel section of the tibial tray presents signs of bone cement.Additionally, the rotating platform appears to be slightly moved to the medial side of the tibia.However, the allegation of loosening cannot be confirmed due to the angles at which the radiographs may have been taken and fact that it is not possible to determine a change in the initial position of the implant based on a single radiograph.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.A manufacturing record evaluation was performed for the finished device 129433125/ 8823244 lot number, and no non-conformances /manufacturing irregularities were identified.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, 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 129433125/ 8823244 lot number, and no non-conformances /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 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 46581-0988 ; 3035526892
• MDR Report Key: 19556331
• Report Number: 1818910-2024-12547
• Device Sequence Number: 6711689
• Product Code: NJL
• UDI-Device Identifier: 10603295025771
• UDI-Public: (01)10603295025771(10)8823244
• 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: 2019
• 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,Followup
• Report Date (Section B): 06/18/2024

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: 05/31/2023
• Device Catalogue Number: 129433125
• Device Lot Number: 8823244
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/28/2024
• Supplement Date Received by Manufacturer: 07/15/2024; 11/19/2024
• Initial Report FDA Received Date: 06/18/2024
• Supplement Report FDA Received Date: 07/16/2024; 11/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/01/2018
• 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: BIOMET CEMENT; HP STRL QUICK DRL PINS; HP STRL THREADED PINS HEADED; PFC*SIGMA/RD/DOME PAT 3PEG,32; SIG RP AOX STB INS SZ3 10; SIGMA PS CEM FEM SZ3 R
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 80 YR
• Patient Sex: Female