MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE PS FEM LT SZ 5 NAR CEM; ATTUNE IMPLANT : KNEE FEMORAL

Model Number 1504-10-125

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Stroke/CVA (1770)

Event Date 06/22/2020

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).Initial reporter occupation: lawyer.This device was also subject of (b)(4) as the patient experienced adverse events on different days with the same device.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Pc was created to capture the event during revision on (b)(6) 2020.During the revision surgery, the patient also sustained a stroke event that caused impaired short-term memory.Doe: (b)(6) 2020.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.Device history lot: dhr reviewed - no deviations or nonconformance's were noted.

• Brand Name: ATTUNE PS FEM LT SZ 5 NAR CEM
• Type of Device: ATTUNE IMPLANT : KNEE FEMORAL
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 12218381
• MDR Text Key: 263183141
• Report Number: 1818910-2021-15885
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 10603295041702
• UDI-Public: 10603295041702
• Combination Product (y/n): N
• PMA/PMN Number: P830055
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 07/01/2021

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?: No
• Device Operator: Health Professional
• Device Model Number: 1504-10-125
• Device Catalogue Number: 150410125
• Device Lot Number: 415871
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/01/2021
• Initial Date FDA Received: 07/23/2021
• Supplement Dates Manufacturer Received: 08/17/2021
• Supplement Dates FDA Received: 08/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ATTUNE FB TIB BASE SZ 4 CEM; ATTUNE MEDIAL DOME PAT 35MM; ATTUNE PS FB INSRT SZ 5 5MM; ATTUNE PS FEM LT SZ 5 NAR CEM; STRYKER COMPETITOR PRODUCTS; UNK CEMENT GENTAMICIN; ATTUNE FB TIB BASE SZ 4 CEM; ATTUNE MEDIAL DOME PAT 35MM; ATTUNE PS FB INSRT SZ 5 5MM; ATTUNE PS FEM LT SZ 5 NAR CEM; STRYKER COMPETITOR PRODUCTS; UNK CEMENT GENTAMICIN
• Patient Outcome(s): Required Intervention