MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE PS FEM LT SZ 7 CEM; ATTUNE IMPLANT : KNEE FEMORAL

Model Number 1504-10-107

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

Patient Problems Loss of Range of Motion (2032); Joint Laxity (4526)

Event Date 04/30/2021

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

It was reported that on (b)(6) 2020, the patient underwent the surgery via tka for both sides of knees.After the operation, the patient had extension restrictions, but the tibia movement was unstable (the tibia moved slightly back and forth), so re-operation for left was performed on (b)(6) 2021.Another company's product was used for the reoperation.The surgery was completed successfully without any surgical delay.No further information available.

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 LT SZ 7 CEM
• Type of Device: ATTUNE IMPLANT : KNEE FEMORAL
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 11825225
• MDR Text Key: 250623923
• Report Number: 1818910-2021-10270
• Device Sequence Number: 1
• Product Code: OIY
• UDI-Device Identifier: 10603295041641
• UDI-Public: 10603295041641
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 04/30/2021

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: 1504-10-107
• Device Catalogue Number: 150410107
• Device Lot Number: 8944578
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/30/2021
• Initial Date FDA Received: 05/14/2021
• Supplement Dates Manufacturer Received: 07/09/2021
• Supplement Dates FDA Received: 07/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ATTUNE MEDIAL ANAT PAT 32MM; ATTUNE PS RP INSRT SZ7 5MM; ATTUNE RP TIB BASE SZ 7 CEM; ATTUNE MEDIAL ANAT PAT 32MM; ATTUNE PS RP INSRT SZ7 5MM; ATTUNE RP TIB BASE SZ 7 CEM
• Patient Outcome(s): Required Intervention