MAUDE Adverse Event Report: DEPUY IRELAND 9616671 ATTUNE REV TIB CEM CONICAL RMR; ATTUNE STEMMABLE TIBIA INSTRUMENTS : STEM TRIALS

Catalog Number	250620103
Medical Device Problem Codes	Entrapment of Device (1212); Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/22/2019
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
It was reported that the primary surgery was performed on (b)(6) 2019 via tka by using attune cr femoral component and stemmable tibia tray.And it was revealed by post-operative x-ray that the trial stem was remained at the distal end of the tibial implant.As a result of confirmation of the instrument used after the surgery, it was found that the trial stem was detached from the distal portion of the reamer which was attached it.Thus, the removal surgery was scheduled to be performed on (b)(6) 2019 by explanting the trial stem from the patient right knee joint.No further information is available.
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.Product complaint # (b)(4).Investigation summary: evaluation of the returned device could not confirm the reported problem.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, a follow-up medwatch will be filed as appropriate.

• Brand Name: ATTUNE REV TIB CEM CONICAL RMR
• Common Device Name: ATTUNE STEMMABLE TIBIA INSTRUMENTS : STEM TRIALS
• Manufacturer (Section D): DEPUY IRELAND 9616671; loughbeg, ringaskiddy co.; cork ; EI
• MDR Report Key: 8662616
• Report Number: 1818910-2019-95023
• Device Sequence Number: 10828856
• Product Code: LXH
• UDI-Device Identifier: 10603295477808
• UDI-Public: 10603295477808
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/21/2019

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: 250620103
• Device Lot Number: NG60813
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/07/2019
• Initial Date Received by Manufacturer: 05/14/2019
• Supplement Date Received by Manufacturer: 06/04/2019; 06/18/2019
• Initial Report FDA Received Date: 06/03/2019
• Supplement Report FDA Received Date: 06/05/2019; 06/19/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 57 YR
• Patient Weight: 73