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

Catalog Number	151640307
Medical Device Problem Code	Disassembly (1168)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/19/2017
Type of Reportable Event	Malfunction
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
The reported implants were implanted to the patient¿s knee joint on (b)(6) 2017.It was reported that the surgeon recognized that the insert was appeared to be dissociated under x-ray on (b)(6) 2017.The surgeon suspected that the insert was not locked properly during the operation.No further information was provided by the hospital.Doi: (b)(6) 2017; dor: unknown; unknown knee.
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 : product code 151640307, lot number 632244.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: ATTUNE PS FB 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: 7194283
• Report Number: 1818910-2018-51325
• Device Sequence Number: 1340643
• Product Code: JWH
• UDI-Device Identifier: 10603295049661
• UDI-Public: 10603295049661
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K111433
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/19/2017

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: 151640307
• Device Lot Number: 632244
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/19/2017
• Supplement Date Received by Manufacturer: 10/03/2018
• Initial Report FDA Received Date: 01/16/2018
• Supplement Report FDA Received Date: 10/03/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1