MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNK SPACER BLOCK/TRIAL SHIM

Catalog Number UNK SPACER BLOCK/TRIAL SHIM

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Insufficient Information (4580)

Event Date 04/05/2022

Event Type  Injury  

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

The patient was revised due to right knee instability , patient is concerned about metal in the back of his knee.Someone in operating room mentioned metal ring possibly came from trial insert from primary tka.The insert was exchanged.Doi: (b)(6) 2014.Dor: (b)(6) 2022.Affected side: right knee.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : the device associated with this report was not returned.An xray and photo was provided for review.The metal bushing was identified post operatively via x-ray and based on the photo appeared to be removed intra operatively during the revision.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 : a manufacturing records evaluation (mre) was not performed as no lot number was provided for this device.

• Brand Name: UNK SPACER BLOCK/TRIAL SHIM
• Type of Device: SPACER BLOCK
• 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: 14167463
• MDR Text Key: 289749655
• Report Number: 1818910-2022-07211
• Device Sequence Number: 1
• Product Code: HTZ
• 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,Followup
• Report Date: 04/21/2022

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?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK SPACER BLOCK/TRIAL SHIM
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/01/2022
• 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
• Treatment: UNK ATTUNE KNEE TIBIAL INSERT
• Patient Outcome(s): Required Intervention
• Patient Age: 75 YR
• Patient Sex: Male
• Patient Weight: 86 KG