MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE CR RP INSRT SZ 3 7MM; ATTUNE IMPLANT : KNEE TIBIAL INSERT

Model Number	1516-30-307
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	12/19/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).
Event or Problem Description
Bearing spun out and knee dislocated.Upsized poly.
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 CR RP INSRT SZ 3 7MM
• Common Device Name: ATTUNE IMPLANT : KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 11112349
• Report Number: 1818910-2021-00096
• Device Sequence Number: 1115219
• Product Code: NJL
• UDI-Device Identifier: 10603295047520
• UDI-Public: 10603295047520
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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: 2020
• 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
• Report Date (Section B): 12/19/2020

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 1516-30-307
• Device Catalogue Number: 151630307
• Device Lot Number: 8627492
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/19/2020
• Supplement Date Received by Manufacturer: 02/05/2021
• Initial Report FDA Received Date: 01/04/2021
• Supplement Report FDA Received Date: 02/08/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 52 YR