MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 MBT CEM KEEL TIB TRAY SZ2; MBT TIBIAL TRAY : KNEE TIBIAL TRAY

Catalog Number 129433120

Device Problem Malposition of Device (2616)

Patient Problem Pain (1994)

Event Date 01/29/2018

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

The primary surgery was performed via tka with sigma prf implants on (b)(6) 2007.The patient complained the pain after the surgery.The surgeon confirmed that the tibial bone implant was inclined slightly forward due to the bone missing at behind the tibia under x-ray.Also, for the femur side, the gap between the bone in the front flange portion was observed, so that the loosening was occurred at the implant.The revisions surgery was performed on (b)(6) 2018 to replace all implants to another manufacturer¿s implants except for sigma/ov/dome (p/n: 960102).The surgeon decided to keep sigma/ov/dome in the patient¿s knee joint because there was a possibility that it becomes too thin if explanted.No further information was provided by the hospital.

Manufacturer Narrative

Investigation summary: no device associated with this report was received for examination.Depuy considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation will 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
• Type of Device: MBT TIBIAL TRAY : KNEE TIBIAL TRAY
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910 ; 700 orthopaedic drive; warsaw IN 46582 0988
• Manufacturer (Section G): DEPUY IRELAND 9616671; loughbeg, ringaskiddy co.; cork ; EI
• Manufacturer Contact: chad gibson ; 700 orthopaedic drive; warsaw, IN 46582-0988 ; 5743725905
• MDR Report Key: 7281853
• MDR Text Key: 100413778
• Report Number: 1818910-2018-53691
• Device Sequence Number: 1
• Product Code: NJL
• UDI-Device Identifier: 10603295025764
• UDI-Public: 10603295025764
• Combination Product (y/n): N
• PMA/PMN Number: P830055
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 01/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 129433120
• Device Lot Number: 2260194
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/10/2018
• Date Device Manufactured: 11/09/2006
• 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