MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US TRUMATCH 3.0 CT PT PLAN; TEMPLATES

Model Number 431001

Device Problem Patient-Device Incompatibility (2682)

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

Event Date 01/01/2022

Event Type  malfunction  

Event Description

It was reported that surgeon only removed 5mm off the medial distal femoral condyle leaving the patient flexed in extension.The distal femoral cutting guide was set at 8 degrees of valgus and 9mm off the distal femoral condyle.We needed to recut the distal femur and proximal tibia twice.The patient also looked like he had a slight flexion contractor prior to operating, was this missed in the ct?".

Manufacturer Narrative

Product complaint # (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Product complaint (b)(4).Investigation summary: the device associated with the reported event was not returned for evaluation.The investigation could not confirm, the reported event.Depuy considers, the investigation closed.Should additional info be received, the investigation will be re-opened as necessary.Device history lot: 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).A manufacturing records evaluation (mre) was not performed.

• Brand Name: TRUMATCH 3.0 CT PT PLAN
• Type of Device: TEMPLATES
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 14171309
• MDR Text Key: 289778645
• Report Number: 1818910-2022-07248
• Device Sequence Number: 1
• Product Code: HWT
• UDI-Device Identifier: 10603295451907
• UDI-Public: 10603295451907
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 431001
• Device Catalogue Number: 431001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/23/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1