MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE PS FB INSRT SZ 6 14MM; ATTUNE IMPLANT : KNEE TIBIAL INSERT

Catalog Number	151640614
Medical Device Problem Code	Off-Label Use (1494)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/27/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: the device associated with this report was not returned and is presumed yet implanted.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.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
Der states that an expired tibial insert was implanted in the patient.During surgery, an expired implant was opened on the field.Prior to implanting, the situation was discovered and the doctor was made aware.Since it was the only insert of the selected size at the hospital, the surgeon decided to implant the product.

• Brand Name: ATTUNE PS FB INSRT SZ 6 14MM
• Common Device Name: ATTUNE IMPLANT : KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 7922938
• Report Number: 1818910-2018-70907
• Device Sequence Number: 19284484
• Product Code: NJL
• UDI-Device Identifier: 10603295050124
• UDI-Public: 10603295050124
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 151640614
• Device Lot Number: 308815
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/13/2018
• Initial Report FDA Received Date: 10/01/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 68 YR