MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US MBT REVISION CEM TIB TRAY SZ 3; MBT TIBIAL TRAY : KNEE TIBIAL TRAY

Catalog Number	129435130
Medical Device Problem Codes	Loss of or Failure to Bond (1068); Migration (4003)
Health Effect - Clinical Code	Pain (1994)
Date of Event	12/01/2015
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # : pc-(b)(4).D4: the device catalog number is unknown; therefore, udi is unavailable.Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, 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 medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
Clinical notification received for revision of left knee to address severe pain and implant loosening/migration of the tibial tray date of implantation: (b)(6) 2001.Date of onset: (b)(6) 2015.Date of revision: (b)(6) 2016.(left knee).Treatment: femur, tibial tray, tibial insert, and patella were revised.
Additional Manufacturer Narrative
Product complaint (b)(4).Investigation summary; no device associated with this report was received for examination.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.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.
Additional Manufacturer Narrative
Product complaint (b)(4).Investigation summary : no device associated with this report was received for examination.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.Device history lot :a manufacturing record evaluation (mre), was not possible because the required lot code was not provided.
Event or Problem Description
Clinical notes received.(b)(6) 2016, the patient had a revision left total knee to address failed tibial component left total knee.During the procedure, the surgeon observed that the tibial tray was grossly loose at the cement/tibial tray interface.The components that were implanted where depuy products, including a depuy patella.Medical records from (b)(6) 2018 note the patient has a painful left knee.The surgeon¿s impression is that that patient has a well fixed knee with great range of motion.There was some mild synovial entrapment, which is not painful.The surgeon noted that the pain was most likely referred from left hip and would benefit from a left hip replacement.(no new pc required at this time, as the pain is being attributed to the patient¿s native left hip).
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.H6: updated pe code from implant loosening interface - unknown to implant loosening: interface - cement to implant.
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.H10 additional narrative: added: d4 (expiration).Corrected: b3, d1, d2a, d2b, d4 (primary udi #.Lot #.Catalog), g4 (pma), h4.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: no device associated with this report was received for examination.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 records evaluation (mre) was not perform.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of the post-market surveillance.If additional information is made available, the investigation will be updated as applicable.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 REVISION CEM TIB TRAY SZ 3
• 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: 17549547
• Report Number: 1818910-2023-16740
• Device Sequence Number: 6657655
• Product Code: NJL
• UDI-Device Identifier: 10603295025962
• UDI-Public: (01)10603295025962(17)251101(10)715889
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2001
• Device Explanted Year: 2016
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 08/15/2023

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: 11/01/2025
• Device Catalogue Number: 129435130
• Device Lot Number: 715889
• 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: 07/31/2023
• Supplement Date Received by Manufacturer: 08/18/2023; 08/24/2023; 08/30/2023; 03/05/2025; 03/12/2025
• Initial Report FDA Received Date: 08/15/2023
• Supplement Report FDA Received Date: 08/23/2023; 08/24/2023; 08/31/2023; 03/12/2025; 03/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/24/2021
• 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: UNKNOWN KNEE FEMORAL; UNKNOWN KNEE PATELLA; UNKNOWN KNEE TIBIAL INSERT
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 79 YR
• Patient Sex: Female
• Patient Weight: 100 KG
• Patient Ethnicity: Non Hispanic