MAUDE Adverse Event Report: DEPUY IRELAND 9616671 ATTUNE PS RP INSRT SZ 6 12MM; ATTUNE IMPLANT : KNEE TIBIAL INSERT

Catalog Number	151650612
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	No Information (3190)
Date of Event	12/08/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 patient was revised to address patella tracking complication.It was also indicated that the surgeon assessed that the femoral component rotation was correct and determined the tibial component rotation was causing the patella tracking complication.The decision was made to remove the tibial component and replace with a stemmed attune tibial component.Upon removing the existing tibia component, the surgeon inserted an osteotome to the anterior aspect of the component and hit it 2-3 times with a mallet.The tibia component dislodged immediately.Based on the ease of removal, the doctor was concerned about the attune tibia's lack of fixation to the cement mantle in light of recent reports questioning this very matter.It is important to note that the tibia was not loose nor was this revision for a loose tibia.It was just concerning to dr.Wade that the tibia came out so easily and had no cement mantle attached to it.Doi- (b)(6) 2016.Dor-(b)(6) 2017, unknown affected side.
Additional Manufacturer Narrative
Product complaint # : (b)(4).Evaluation of the returned device confirms wear.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.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 RP INSRT SZ 6 12MM
• Common Device Name: ATTUNE IMPLANT : KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY IRELAND 9616671; loughbeg, ringaskiddy co.; cork ; EI
• MDR Report Key: 7424581
• Report Number: 1818910-2018-57180
• Device Sequence Number: 173155
• Product Code: NJL
• UDI-Device Identifier: 10603295052616
• UDI-Public: 10603295052616
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• 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
• Report Date (Section B): 04/05/2018

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: 151650612
• Device Lot Number: 8471679
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/23/2018
• Initial Date Received by Manufacturer: 04/05/2018
• Supplement Date Received by Manufacturer: 04/05/2018
• Initial Report FDA Received Date: 04/12/2018
• Supplement Report FDA Received Date: 04/13/2018
• 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: 61 YR