MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US MBT CEM TIBIAL TRAY SZ2.5; MBT TIBIAL TRAY : KNEE TIBIAL TRAY

Model Number	1294-31-125
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Pain (1994); No Code Available (3191)
Date of Event	02/14/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(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
Revision right tkr.Patient underwent right pfc rp, total knee replacement on (b)(6) 2016.Presented to surgeon with complaint of tibial pain and instability.Suspected loose tibial tray.Upon opening the knee, surgeon stated it appeared the tray had subsided on the lateral side.Surgeon proceeded to revise the tibial tray component only to mbt tray with tibial sleeve and stem and upsized the insert.No ae reported, no delay.
Additional Manufacturer Narrative
Product complaint (b)(4).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.  h10 additional narrative:  udi: (b)(4).Added: d4(expiration date).
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 reported incident(s) against the provided product/lot combination(s) 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.Corrective action was not indicated.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.

• Brand Name: MBT CEM TIBIAL 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
• MDR Report Key: 9776588
• Report Number: 1818910-2020-06572
• Device Sequence Number: 16610754
• Product Code: NJL
• UDI-Device Identifier: 10603295025597
• UDI-Public: 10603295025597
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/14/2020

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: 02/29/2020
• Device Model Number: 1294-31-125
• Device Catalogue Number: 129431125
• Device Lot Number: 8080031
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/14/2020
• Supplement Date Received by Manufacturer: 02/28/2020; 04/07/2020
• Initial Report FDA Received Date: 03/02/2020
• Supplement Report FDA Received Date: 03/13/2020; 04/15/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: PFC SIGMARP STB TB IN 3 10.0; PFC SIGMARP STB TB IN 3 10.0; PFC*SIGMA C/S NPOR FEM RT SZ 3; PFC*SIGMA/OV/DOME PAT 3PEG,35; SMARTSET GHV GENTAMICIN 40G; SMARTSET GHV GENTAMICIN 40G
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 71 YR