MAUDE Adverse Event Report: DEPUY IRELAND 9616671 ATTUNE CR RP INSRT SZ 7 6MM; ATTUNE IMPLANT : KNEE TIBIAL INSERT

Catalog Number	151630706
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	Not Applicable (3189)
Date of Event	08/20/2019
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
It was reported that during trialing of the revision knee with the real tibial tray cemented into place it was deemed a 6 mm cr rp insert trial offered desired stability.At this point a real sz 7 6 mm cr rp attune insert was opened and implanted.It was immediately clear the real insert tension was not the same as the previous trial of the same size.The surgeon removed the real implant and trialed the 6 mm construct again and was again satisfied with the way the trial felt.The real implant was again inserted and found to be less stable than the trial.At this point a decision was made to open a real 7 mm insert and see how that felt and it offered the same stability as the 6 mm trial.Please note, this is a second independent device report for the same patient.
Event or Problem Description
Upon receipt dimensional has been added to the product experienced code.
Additional Manufacturer Narrative
Product complaint # (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Additional narrative: corrected : d10, h3.Product complaint # (b)(4).Investigation summary: examination of the returned device did not find any evidence confirming the reported event.No product contribution to the reported event was identified.The investigation findings did not indicate that a broader investigation or corrective action was necessary.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, a follow-up medwatch will be filed as appropriate.

• Brand Name: ATTUNE CR RP INSRT SZ 7 6MM
• Common Device Name: ATTUNE IMPLANT : KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY IRELAND 9616671; loughbeg, ringaskiddy co.; cork ; EI
• MDR Report Key: 8989981
• Report Number: 1818910-2019-103929
• Device Sequence Number: 3380231
• Product Code: NJL
• UDI-Device Identifier: 10603295047995
• UDI-Public: 10603295047995
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/20/2019

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: 151630706
• Device Lot Number: 8249479
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/11/2019
• Initial Date Received by Manufacturer: 08/20/2019
• Supplement Date Received by Manufacturer: 09/09/2019; 10/15/2019
• Initial Report FDA Received Date: 09/11/2019
• Supplement Report FDA Received Date: 10/03/2019; 10/15/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1