MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE PS FEM RT SZ 6 CEM ATTUNE IMPLANT : KNEE FEMORAL

Model Number 1504-10-206

Device Problem Loss of or Failure to Bond (1068)

Patient Problem Insufficient Information (4580)

Event Date 07/21/2021

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 to address loosening of the femoral and tibial components at the cement to implant interface. It was also reported that it did not bond well. A depuy cement was used. No surgical delay. Doi: (b)(6) 2019, dor: (b)(6) 2021. Right knee.

• Brand Name: ATTUNE PS FEM RT SZ 6 CEM
• Type of Device: ATTUNE IMPLANT : KNEE FEMORAL
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): DEPUY IRELAND 9616671; loughbeg, ringaskiddy co.; cork ; EI
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 12306553
• Report Number: 1818910-2021-17565
• Device Sequence Number: 1
• Product Code: OIY
• UDI-Device Identifier: 10603295041771
• UDI-Public: 10603295041771
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P830055
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 07/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 1504-10-206
• Device Catalogue Number: 150410206
• Device Lot Number: 7931514
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 08/24/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/19/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Age: 49 YR
• Patient Treatment(s): ATTUNE FB TIB BASE SZ 6 CEM; ATTUNE PS FB INSRT SZ 6 8MM; ATTUNE PS FEM RT SZ 6 CEM; DEPUY CEMENT
• Patient Outcome(s): Required Intervention