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 Joint Laxity (4526)

Event Date 10/21/2021

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

Patient was revised due to instability, medial tibial collapse and loosening of the tibial component at the cement to implant interface.Competitor cement was used.The patella component was retained while all other components was revised.Doi: (b)(6) 2016 dor: (b)(6) 2021 left 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 : a manufacturing record evaluation (mre), was not possible because the required lot code was not provided.

• 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
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 12751968
• MDR Text Key: 280140871
• Report Number: 1818910-2021-24416
• Device Sequence Number: 1
• Product Code: OIY
• UDI-Device Identifier: 10603295041702
• UDI-Public: 10603295041702
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P830055
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2021
• 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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/23/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: ATTUNE FB TIB BASE SZ 5 CEM; ATTUNE MEDIAL ANAT PAT 38MM; ATTUNE PS FB INSRT SZ 5 7MM; ATTUNE PS FEM LT SZ 5 NAR CEM; COMPETITOR CEMENT; ATTUNE FB TIB BASE SZ 5 CEM; ATTUNE MEDIAL ANAT PAT 38MM; ATTUNE PS FB INSRT SZ 5 7MM; ATTUNE PS FEM LT SZ 5 NAR CEM; COMPETITOR CEMENT
• Patient Outcome(s): Required Intervention
• Patient Age: 66 YR
• Patient Sex: Female
• Patient Weight: 127 KG