MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE MEDIAL ANAT PAT 41MM; ATTUNE IMPLANT : KNEE PATELLA

Model Number 1518-10-041

Device Problem Fracture (1260)

Patient Problem Fall (1848)

Event Date 08/24/2021

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 due to fall that fractured patella and loosening of the tibial component at the cement to implant interface.Unknown cement was used.Doi: (b)(6) 2015 - 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 : product code 151810041, work order (b)(4) was manufactured on 18-february-2013.(b)(4) parts were manufactured per specification and all raw materials met specification.There was no scrap associated with this lot.There was no material reprocessing reports (mrr) associated with this lot.There were no non-conformances associated with this lot.

• Brand Name: ATTUNE MEDIAL ANAT PAT 41MM
• Type of Device: ATTUNE IMPLANT : KNEE PATELLA
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 12474290
• MDR Text Key: 271468345
• Report Number: 1818910-2021-20126
• Device Sequence Number: 1
• Product Code: OIY
• UDI-Device Identifier: 10603295056652
• UDI-Public: 10603295056652
• 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: 08/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1518-10-041
• Device Catalogue Number: 151810041
• Device Lot Number: 3576069
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ATTUNE CR FB INSRT SZ 7 5MM; ATTUNE CR FEM RT SZ 7 CEM; ATTUNE FB TIB BASE SZ 7 CEM; ATTUNE MEDIAL ANAT PAT 41MM; UNKNOWN BONE CEMENT; ATTUNE CR FB INSRT SZ 7 5MM; ATTUNE CR FEM RT SZ 7 CEM; ATTUNE FB TIB BASE SZ 7 CEM; ATTUNE MEDIAL ANAT PAT 41MM; UNKNOWN BONE CEMENT
• Patient Outcome(s): Required Intervention
• Patient Age: 75 YR
• Patient Weight: 82