MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE MEDIAL DOME PAT 38MM; ATTUNE IMPLANT : KNEE PATELLA

Model Number 1518-20-038

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

Patient Problems Fall (1848); Joint Laxity (4526)

Event Date 01/06/2021

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 the patient apparently had fallen at the hospital and at the rehab as per the doctor that caused a ligament loosening issue.Loosening of the femoral component was noted at an unknown interface.Depuy cement was used.No surgical delay was noted.Doi: (b)(6) 2020, dor: (b)(6) 2021, left knee.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.Depuy synthes considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation may 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).Where the lot code was provided, a manufacturing records evaluation (mre) was not performed.

Event Description

A.In the der, loosening was marked as "yes" of the femoral component but the interface was marked as "not applicable".Please verify if there was really loosening.If yes, at what interface did the loosening occur? b.Please clarify what "ligament loosening issue" means.Was the knee became unstable or this means loosening of the femoral component? c.Please confirm if there were any depuy instrumentation that broke during surgery? if yes, please provide the details.Answer: yes the ligaments were unstable bc of the fall/falls per the doctor.The femur component was not loose on the interface or loose.I may have miss marked that.No instruments were broke.

Manufacturer Narrative

Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.H10 additional narrative: added: b5.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• Brand Name: ATTUNE MEDIAL DOME PAT 38MM
• Type of Device: ATTUNE IMPLANT : KNEE PATELLA
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 11200913
• MDR Text Key: 227732519
• Report Number: 1818910-2021-01494
• Device Sequence Number: 1
• Product Code: OIY
• UDI-Device Identifier: 10603295056690
• UDI-Public: 10603295056690
• 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,Followup
• Report Date: 01/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/20/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 1518-20-038
• Device Catalogue Number: 151820038
• Device Lot Number: 9634153
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ATTUNE MEDIAL DOME PAT 38MM.; ATTUNE PS FEM LT SZ 4 CEM.; ATTUNE PS RP INSRT SZ 4 16MM.; ATTUNE RP TIB BASE SZ 4 CEM.; SMARTSET HV BONE CEMENT 40G.; ATTUNE MEDIAL DOME PAT 38MM; ATTUNE PS FEM LT SZ 4 CEM; ATTUNE PS RP INSRT SZ 4 16MM; ATTUNE RP TIB BASE SZ 4 CEM; SMARTSET HV BONE CEMENT 40G
• Patient Outcome(s): Required Intervention
• Patient Age: 68 YR