MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 MBT CEM KEEL TIB TRAY SZ4; KNEE TIBIAL TRAY

Catalog Number 129433140

Device Problem Malposition of Device (2616)

Patient Problems No Consequences Or Impact To Patient (2199); Not Applicable (3189)

Event Date 04/11/2018

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

Der states that the tray seemed to be in poor alignment.The tray was taken out and put in a mbt rev tray and new insert.Doi: (b)(6) 2014; dor: (b)(6) 2018; right knee.

Manufacturer Narrative

(b)(4).Investigation summary: no device associated with this report was received for examination.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 SZ4
• Type of Device: KNEE TIBIAL TRAY
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• Manufacturer (Section G): DEPUY IRELAND 9616671; 700 orthopaedic drive; warsaw 46582
• Manufacturer Contact: chad gibson ; 700 orthopaedic drive; warsaw, IN 46582-0988 ; 5743725905
• MDR Report Key: 7494239
• MDR Text Key: 107587646
• Report Number: 1818910-2018-59105
• Device Sequence Number: 1
• Product Code: NJL
• UDI-Device Identifier: 10603295025795
• UDI-Public: 10603295025795
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P830055
• 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: 04/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/08/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 129433140
• Device Lot Number: 7862035
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/12/2018
• Date Device Manufactured: 03/11/2014
• 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: 74 YR
• Patient Weight: 111