MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US MBT TRAY SLEEVE POR M/L 37MM; MBT TIBIAL TRAY : KNEE TIBIAL TRAY ACCESSORY

Model Number 1294-54-100

Device Problem Corroded (1131)

Patient Problem No Code Available (3191)

Event Date 09/19/2019

Event Type  Injury  

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 Description

Hcp reported to (b)(6): "relative movement of the femoral shield.The epiphyseal zone is loosened and the plug cone to the metaphyseal sleeve shows distinct corrosion marks (fretting).Loosening of the femoral component after knee-tep-change in (b)(6) 2018.Knee-tep lcs revision on (b)(6) 2019.Partially coupled, stalk guided, partially cemented.".

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.

Manufacturer Narrative

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.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.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.Device history lot : null.Device history batch : null.Device history review : null if information is obtained that was not available for the initial medwatch, a follow-up medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: MBT TRAY SLEEVE POR M/L 37MM
• Type of Device: MBT TIBIAL TRAY : KNEE TIBIAL TRAY ACCESSORY
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 9416113
• MDR Text Key: 185667980
• Report Number: 1818910-2019-120662
• Device Sequence Number: 1
• Product Code: NJL
• UDI-Device Identifier: 10603295026419
• UDI-Public: 10603295026419
• Combination Product (y/n): N
• PMA/PMN Number: P830055
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Type of Report: Initial,Followup,Followup
• Report Date: 09/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1294-54-100
• Device Catalogue Number: 129454100
• Device Lot Number: HN8703
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: COMPETITOR BONE CEMENT; LCS COMP VVC INS STD 10MM; MBT REVISION CEM TIB TRAY SZ 2; UNIVERSAL STEM 75X12MM FLUTED
• Patient Outcome(s): Required Intervention
• Patient Age: 78 YR
• Patient Weight: 58