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.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.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 : the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.

• 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
• MDR Report Key: 12306553
• MDR Text Key: 265981045
• Report Number: 1818910-2021-17565
• Device Sequence Number: 1
• Product Code: OIY
• UDI-Device Identifier: 10603295041771
• UDI-Public: 10603295041771
• Combination Product (y/n): N
• PMA/PMN Number: P830055
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• 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: Health Professional
• Device Model Number: 1504-10-206
• Device Catalogue Number: 150410206
• Device Lot Number: 7931514
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ATTUNE FB TIB BASE SZ 6 CEM; ATTUNE PS FB INSRT SZ 6 8MM; ATTUNE PS FEM RT SZ 6 CEM; DEPUY CEMENT; 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
• Patient Age: 49 YR