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 Joint Laxity (4526)

Event Date 06/13/2022

Event Type  Injury  

Event Description

It was reported that this patient had a right total attune knee with laxity.Dr.L.Did the knee and it was unknown when it was done.The surgeon planned on putting in a thicker tibial insert to tighten up the laxity but when the surgeon tapped on the femur and tibial tray, they both came out with multiple taps.There was cement on the backside of the femur, and no cement stuck to the backside of the tibial tray.The patella was well fixed and retained.The femoral component and tibial component were revised.Loosening was noted of the femur at the cement to bone interface and loosening of the tibia at the cement to implant interface.Unknown bone cement was used.There was no surgical delay.Doi: unknown.Dor: (b)(6) 2022.Affected side: right knee.

Manufacturer Narrative

Product complaint # pc-(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 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 IN ; EI
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 14843206
• MDR Text Key: 294886722
• Report Number: 1818910-2022-11910
• Device Sequence Number: 1
• Product Code: HWT
• 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: 06/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 06/13/2022
• Initial Date FDA Received: 06/28/2022
• Supplement Dates Manufacturer Received: 07/04/2022
• Supplement Dates FDA Received: 07/05/2022
• 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 TIBIAL INSERT; UNK KNEE FEMORAL ATTUNE PS; UNKNOWN BONE CEMENT
• Patient Outcome(s): Required Intervention
• Patient Age: 66 YR
• Patient Sex: Male