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

Model Number 1294-33-140

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); No Code Available (3191)

Event Date 11/03/2020

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 patient's knee was revised due to pain.Doi: (b)(6) 2014, dor: (b)(6) 2020, left 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 review : the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).Where the lot code was provided, a manufacturing records evaluation (mre) was not performed.

• Brand Name: MBT CEM KEEL TIB TRAY SZ4
• Type of Device: MBT TIBIAL TRAY : KNEE TIBIAL TRAY
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 10850367
• MDR Text Key: 216653919
• Report Number: 1818910-2020-24739
• Device Sequence Number: 1
• Product Code: MRA
• UDI-Device Identifier: 10603295025795
• UDI-Public: 10603295025795
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 11/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 1294-33-140
• Device Catalogue Number: 129433140
• Device Lot Number: 7818256
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: PFC SIGMARP STB TB IN 5 10.0; STRYKER COMPETITOR BONE CEMENT; PFC SIGMARP STB TB IN 5 10.0; STRYKER COMPETITOR BONE CEMENT
• Patient Outcome(s): Required Intervention