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

Catalog Number 129433125

Device Problem Loss of or Failure to Bond (1068)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/01/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Additional 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 due to loosening of femoral and tibial components patient consequence? no.Is the information being submitted for this complaint all the details that are known/available regarding this event? yes.

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.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 CEM KEEL TIB TRAY SZ2.5
• Type of Device: MBT TIBIAL TRAY : KNEE TIBIAL TRAY
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY IRELAND 9616671; loughbeg ringaskiddy; cork ; EI
• Manufacturer Contact: chad gibson ; 700 orthopaedic drive; warsaw, IN 46581-0988 ; 5743725905
• MDR Report Key: 7198842
• MDR Text Key: 97482239
• Report Number: 1818910-2018-51369
• Device Sequence Number: 1
• Product Code: MRA
• UDI-Device Identifier: 10603295025771
• UDI-Public: 10603295025771
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P070026
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 12/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/17/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 129433125
• Device Lot Number: 2748971
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/28/2018
• Date Device Manufactured: 10/26/2008
• 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: 55 YR
• Patient Weight: 98