MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US MBT POR KEEL TIB TRAY SZ3; MBT TIBIAL TRAY : KNEE TIBIAL TRAY

Model Number	1294-34-130
Medical Device Problem Code	Osseointegration Problem (3003)
Health Effect - Clinical Codes	Pain (1994); Inadequate Osseointegration (2646)
Date of Event	03/18/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint #: (b)(4).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
Patient was revised due to pain and loosening of the tibial tray at the implant to bone interface.Patient had a right knee replacement with a different surgeon in 2019, with sigma cruciate retaining porous coated tibial and femoral components.Patient reported having pain as early as three months after surgery, increasing to the point that patient visited the surgeon for a solution.Surgeon suggested a revision to cemented components.The femoral components was well fixed, the tibial component less so but did not appear grossly loose.The rp curved insert showed no wear on gross examination.Surgeon re-implanted a primary attune ps femoral component, with a statement revision tibial tray and a 14 mm ps fixed bearing insert.Surgeon went well, with a satisfactory outcome.Doi: (b)(6) 2019 dor: (b)(6) 2021 right knee.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.A worldwide complaint database search found no other related reported incidents against the provided product code/lot number combination since release for distribution.Based on previous investigations, this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications.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.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).Where the lot code was provided, a manufacturing records evaluation (mre) was not performed.

• Brand Name: MBT POR KEEL TIB TRAY SZ3
• Common Device Name: MBT TIBIAL TRAY : KNEE TIBIAL TRAY
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 11628833
• Report Number: 1818910-2021-07307
• Device Sequence Number: 4009939
• Product Code: NJL
• UDI-Device Identifier: 10603295025870
• UDI-Public: 10603295025870
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/18/2021

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 Model Number: 1294-34-130
• Device Catalogue Number: 129434130
• Device Lot Number: 9177342
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/18/2021
• Supplement Date Received by Manufacturer: 04/29/2021
• Initial Report FDA Received Date: 04/07/2021
• Supplement Report FDA Received Date: 05/03/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 64 YR
• Patient Weight: 141