MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE PS RP INSRT SZ 4 16MM; ATTUNE IMPLANT : KNEE TIBIAL INSERT

Model Number	1516-50-416
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Fall (1848); Joint Laxity (4526)
Date of Event	01/06/2021
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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.
Additional 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.
Event or Problem 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.
Additional 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.

• Brand Name: ATTUNE PS RP INSRT SZ 4 16MM
• Common Device Name: ATTUNE IMPLANT : KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 11200918
• Report Number: 1818910-2021-01495
• Device Sequence Number: 11320671
• Product Code: NJL
• UDI-Device Identifier: 10603295052357
• UDI-Public: 10603295052357
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/06/2021

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
• Operator of Device: Health Professional
• Device Model Number: 1516-50-416
• Device Catalogue Number: 151650416
• Device Lot Number: 8936974
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/06/2021
• Supplement Date Received by Manufacturer: 01/21/2021; 02/16/2021
• Initial Report FDA Received Date: 01/20/2021
• Supplement Report FDA Received Date: 02/10/2021; 02/17/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 68 YR