MAUDE Adverse Event Report: DEPUY ORTHOPAEDIC INC, 1818910 MBT CEM KEEL TIB TRAY SZ3; MBT TIBIAL TRAY : KNEE TIBIAL TRAY

Catalog Number 129433130

Device Problems Failure To Adhere Or Bond (1031); Migration or Expulsion of Device (1395)

Patient Problems Not Applicable (3189); No Code Available (3191)

Event Date 04/18/2018

Event Type  Injury  

Manufacturer Narrative

If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Patient was revised to address subsidence and loosening of the tibial component at cement to implant interface.Cement manufacturer is unknown.It was also reported that the surgeon removed the tibial tray and insert and replaced with a new tibial tray/tibial stem and sleeve construct.Doi: (b)(6) 2014; dor: (b)(6) 2018; right knee.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.Depuy synthes considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.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 will be filed as appropriate.

• Brand Name: MBT CEM KEEL TIB TRAY SZ3
• Type of Device: MBT TIBIAL TRAY : KNEE TIBIAL TRAY
• Manufacturer (Section D): DEPUY ORTHOPAEDIC INC, 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• Manufacturer (Section G): DEPUY IRELAND 961610 ; loughbeg ringaskiddy; cork ; EI
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic drive; warsaw, IN 46582-0988 ; 6103142063
• MDR Report Key: 7513889
• MDR Text Key: 108239464
• Report Number: 1818910-2018-59603
• Device Sequence Number: 1
• Product Code: MRA
• UDI-Device Identifier: 10603295025788
• UDI-Public: 10603295025788
• Combination Product (y/n): N
• Reporter Country Code: EI
• PMA/PMN Number: P070026
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 04/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/15/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 129433130
• Device Lot Number: 7801954
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/21/2018
• Date Device Manufactured: 09/07/2012
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 57 YR