MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNK ATTUNE KNEE TIBIAL TRAY

Catalog Number UNK ATTUNE KNEE TIBIAL TRAY

Device Problem Loss of or Failure to Bond (1068)

Patient Problem Unspecified Infection (1930)

Event Date 02/17/2022

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 for suspected infection.The tibial baseplate had debonded from the cement mantle.Unknown bone cement was used.All components were removed, and an antibiotic spacer was put in place.No surgical delay.Doi: unknown, dor: (b)(6) 2022, affected side: left knee.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: no device associated with this complaint was received for investigation.The photo investigation found evidence of loosening, confirming the reported allegation.Received, the information will be reviewed and the investigation may be re-opened as necessary.Device history lot: a device history record (dhr) review or manufacturing records evaluation (mre) was not possible because the required lot code was not provided.

• Brand Name: UNK ATTUNE KNEE TIBIAL TRAY
• Type of Device: TIBIAL TRAY
• 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: 13731587
• MDR Text Key: 286992924
• Report Number: 1818910-2022-04476
• Device Sequence Number: 1
• Product Code: JWH
• 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: 03/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK ATTUNE KNEE TIBIAL TRAY
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/14/2022
• 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: Initial
• Patient Sequence Number: 1
• Treatment: UNK ATTUNE KNEE PATELLA.; UNK ATTUNE KNEE TIBIAL INSERT.; UNK ATTUNE KNEE TIBIAL TRAY.; UNK KNEE FEMORAL ATTUNE PS.
• Patient Outcome(s): Required Intervention
• Patient Age: 74 YR
• Patient Sex: Female
• Patient Weight: 104 KG