MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US ATT THEMIS BAL FEM POST RT; SIZING/MEASURING INSTRUMENTS

Model Number 2545-06-002

Device Problems Mechanical Problem (1384); Unintended Movement (3026)

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

Event Date 10/18/2021

Event Type  malfunction  

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.

Event Description

End of afternoon, the surgeon had issue to distract the knee with the themis.The instrument was introduced in extension, the surgeon was supporting the back of the knee but when he was quizzing the handle to distract the spring was compressing (up to maximum) but the tenser was not applying any tension on the articulation (he was not moving); the tenser had space in the articulation, it was moving a bit but was not distracting.Out side the knee the tenser was distracting when squeezing the handle but it was a bit difficult to bring it back to 0 and when the sales rep was mounting it she filled difficult to put the femoral part in the tibial part.This problem happened already once a few week ago with the same problem.But they were not thinking of issue with the themis (see complaint (b)(4)).The sales rep come on (b)(6) 2021 to see what was happening.It was a right knee.No additional time of the surgery and no negative effect for the patient the surgeon used the spacer bock to check the spaces.The themis is on consignment, it will be sent back to saint priest for investigation.(b)(6) 2021 the surgeon did a second knee with themis and it works well.

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.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post market surveillance.

• Brand Name: ATT THEMIS BAL FEM POST RT
• Type of Device: SIZING/MEASURING INSTRUMENTS
• 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: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 12721578
• MDR Text Key: 279095738
• Report Number: 1818910-2021-24066
• Device Sequence Number: 1
• Product Code: HWT
• UDI-Device Identifier: 10603295496960
• UDI-Public: 10603295496960
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/29/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2545-06-002
• Device Catalogue Number: 254506002
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/02/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1