MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US MBT REV TRAY TRL W/STEM SZ4; KNEE INSTRUMENT : TIBIAL BASE PLATES

Model Number 2294-35-140

Device Problems Device-Device Incompatibility (2919); Material Twisted/Bent (2981); Naturally Worn (2988)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/09/2021

Event Type  malfunction  

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

It was reported that during a complex knee using the tc3 and revision mbt system the sleeve trials are not connecting to the tray trials.Surgeon feels the set is worn out, too old and the trials need to be replaced.Requested all sizes to be replaced.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: the device associated with this report was not returned for evaluation.The investigation could not draw any conclusions about the reported event without the device to examine.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.Device history lot : lot information not available corrected: h6 (medical device problem code).

• Brand Name: MBT REV TRAY TRL W/STEM SZ4
• Type of Device: KNEE INSTRUMENT : TIBIAL BASE PLATES
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 12042060
• MDR Text Key: 257500558
• Report Number: 1818910-2021-13291
• Device Sequence Number: 1
• Product Code: HWT
• UDI-Device Identifier: 10603295113454
• UDI-Public: 10603295113454
• 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: 06/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2294-35-140
• Device Catalogue Number: 229435140
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/09/2021
• Initial Date FDA Received: 06/22/2021
• Supplement Dates Manufacturer Received: 07/30/2021
• Supplement Dates FDA Received: 08/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 71 YR