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

Model Number 1504-10-105

Device Problem Use of Device Problem (1670)

Patient Problem Adhesion(s) (1695)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Initial reporter occupation: lawyer.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Medical records received (b)(6) 2018.Records indicate patient received an attune tka.No allegations provided of patient injury or product failure, nor report of revision.The patient underwent a left total knee arthroplasty on (b)(6) 2015 utilizing depuy synthes components including patella resurfacing with a competitor cement with no complications.On (b)(6) 2016, she underwent a revision for aseptic failure of the left tka.Intraoperatively, extensive scarring was found.The surgeon required osteotomes to remove the femoral and tibial components and any indication of loosening was never stated.The surgeon states that 6 degrees of external rotation from the previous external rotation was cut to "improve the alignment of the femoral component." no other complications identified.Doi:(b)(6) 2015 dor: unknown (left).

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.

• Brand Name: ATTUNE PS FEM LT SZ 5 CEM
• Type of Device: ATTUNE IMPLANT : KNEE FEMORAL
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 12474134
• MDR Text Key: 271467898
• Report Number: 1818910-2021-20118
• Device Sequence Number: 1
• Product Code: OIY
• UDI-Device Identifier: 10603295041627
• UDI-Public: 10603295041627
• Combination Product (y/n): N
• PMA/PMN Number: P830055
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup
• Report Date: 09/13/2018

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 Expiration Date: 03/31/2024
• Device Model Number: 1504-10-105
• Device Catalogue Number: 150410105
• Device Lot Number: 7873609
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/31/2021
• Initial Date FDA Received: 09/15/2021
• Supplement Dates Manufacturer Received: 09/16/2021
• Supplement Dates FDA Received: 09/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ATTUNE MEDIAL DOME PAT 29MM; ATTUNE PS FEM LT SZ 5 CEM; ATTUNE PS RP INSRT SZ 5 14MM; ATTUNE RP TIB BASE SZ 5 CEM; STRYKER BONE CEMENT; STRYKER BONE CEMENT; ATTUNE MEDIAL DOME PAT 29MM; ATTUNE PS FEM LT SZ 5 CEM; ATTUNE PS RP INSRT SZ 5 14MM; ATTUNE RP TIB BASE SZ 5 CEM; STRYKER BONE CEMENT; STRYKER BONE CEMENT
• Patient Outcome(s): Required Intervention
• Patient Age: 58 YR