MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE PS FB INSRT SZ 7 20MM; ATTUNE IMPLANT : KNEE TIBIAL INSERT

Catalog Number	151640720
Medical Device Problem Codes	Fitting Problem (2183); Connection Problem (2900)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/06/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(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
Der states for hemarthrosis of knee; surgeon questioned whether joint was infected.Cultures sent in but still awaiting results as of 15:00 on (b)(6) 2017.Femoral component suspected to be loose.Surgeon explanted femur, poly and tray revising with attune revision system.It was also reported that the femur was loose at the bone/cement interface.Competitor cement was used.Additionally, surgeon was unable to seat final poly insert.The posterior aspect of the poly sat flush with the tray but felt that anterior aspect never seated.He requested the product be sent back to investigate.Doi: (b)(6) 2017 dor: (b)(6) 2017 right knee surgical delay of 6 minutes.
Additional Manufacturer Narrative
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Additional Manufacturer Narrative
Product complaint #: (b)(4).Investigation summary: evaluation of the returned device confirms the reported event.Depuy considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.Device history lot = > product code 151640720, lot number 517965 device history review = > dhr reviewed no related nonconformances that would have contributed to the reported event.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 7 20MM
• Common Device Name: ATTUNE IMPLANT : KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 7163639
• Report Number: 1818910-2018-50168
• Device Sequence Number: 1446636
• Product Code: JWH
• UDI-Device Identifier: 10603295050292
• UDI-Public: 10603295050292
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K111433
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/06/2017

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: 151640720
• Device Lot Number: 517965
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2017
• Initial Date Received by Manufacturer: 12/06/2017
• Supplement Date Received by Manufacturer: 12/19/2017; 03/08/2018
• Initial Report FDA Received Date: 01/04/2018
• Supplement Report FDA Received Date: 01/08/2018; 03/08/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 69 YR