MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE CR RP INSRT SZ5 7MM; ATTUNE IMPLANT : KNEE TIBIAL INSERT

Catalog Number	151630507
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	11/08/2018
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
Clinical adverse event received for posterior collapse of the tibial metaphyseal bone with increased slope of the tibial component and posterior subluxation of the femoral component.Event is serious and is considered moderate.Event is definitely related to device and possibly related to procedure.Date of implantation: (b)(6) 2017; date of event (onset): (b)(6) 2018; (left knee).
Additional Manufacturer Narrative
This product was reported in error.No patient death, serious injury or evidence of reportable product malfunction occurred.Depuy considers the investigation closed at this time.Should any additional information be received to change the outcome of the performed investigation, the complaint will be re-opened.

• Brand Name: ATTUNE CR RP INSRT SZ5 7MM
• Common Device Name: ATTUNE IMPLANT : KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 8842894
• Report Number: 1818910-2019-99693
• Device Sequence Number: 372212
• Product Code: NJL
• UDI-Device Identifier: 10603295047766
• UDI-Public: 10603295047766
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/12/2019

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 Catalogue Number: 151630507
• Device Lot Number: 8520078
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/12/2019
• Supplement Date Received by Manufacturer: 09/09/2019
• Initial Report FDA Received Date: 07/30/2019
• Supplement Report FDA Received Date: 09/10/2019
• 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 ANAT PAT 35MM; DEPUY CMW 2 20G; ATTUNE MEDIAL ANAT PAT 35MM; DEPUY CMW 2 20G
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 74 YR
• Patient Weight: 100