MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 UNK KNEE TIBIAL TRAY ATTUNE RP

Catalog Number UNK KNEE TIBIAL TRAY ATTUNE RP

Device Problem Loss of or Failure to Bond (1068)

Patient Problem Insufficient Information (4580)

Event Date 05/23/2022

Event Type  Injury  

Manufacturer Narrative

Product complaint # pc-(b)(4).

Event Description

It was reported that the patient had a left total attune knee with a loose tibial tray.It is unknown when the knee was done.The surgeon revised the tibial tray.The femur and patella are well fixed and retained.The loosening interface was at the cement to implant.Doi: unknown.Dor: (b)(6) 2022.Affected side: left knee.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.A worldwide lot specific complaint database search, or manufacturing record evaluation, was not possible as the required lot number was not provided.The information received will be retained for trend analysis, post market surveillance, or other events within the quality system.Device history lot: a manufacturing record evaluation (mre), was not possible because the required lot code was not provided.

• Brand Name: UNK KNEE TIBIAL TRAY ATTUNE RP
• Type of Device: KNEE TIBIAL TRAY
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): DEPUY IRELAND 9616671; loughbeg, ringaskiddy co.; cork ; EI
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 14653093
• MDR Text Key: 293693476
• Report Number: 1818910-2022-10573
• 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: 06/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/10/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK KNEE TIBIAL TRAY ATTUNE RP
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/13/2022
• 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: 5 ATTUNE RP TRAY; 5X10MM PS RP ATTUNE INSERT; UNK ATTUNE FEMORAL; UNK ATTUNE KNEE PATELLA; UNKNOWN BONE CEMENT
• Patient Outcome(s): Required Intervention
• Patient Age: 74 YR
• Patient Sex: Female