MAUDE Adverse Event Report: DEPUY INT'L LTD. 8010379 ATTUNE CEMENTED STEM 14X80MM; KNEE STEMS

Model Number	1512-14-080
Medical Device Problem Code	Unintended Compatibility (4047)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/27/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the torque wrench from the assembly pan had slipped out of the groove of the cemented stem while locking it in.It was cold welded and couldn¿t get it off.Had to open another assembly pan and a new cemented stem.The wrench and the stem were being sent back for analysis.The doctor suggested that the wrench was either worn (which he didn¿t notice any evidence of it), or the metal was too soft to be able to contour that much.A surgical delay of 3-5 minutes was noted.
Additional Manufacturer Narrative
Product complaint #: (b)(4).Investigation summary: the device associated with this report was received for examination.Visual inspection of the device found it was jammed with the atun rev assem wrnch adaptor.Additional findings are wear markings on the stem grooves where the steam and the wrench became jammed.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.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.

• Brand Name: ATTUNE CEMENTED STEM 14X80MM
• Common Device Name: KNEE STEMS
• Manufacturer (Section D): DEPUY INT'L LTD. 8010379; st anthonys road; leeds LS11 8 DT; UK LS11 8 DT
• Manufacturer (Section G): DEPUY INT'L LTD. 8010379; st anthonys road; randalls road; leeds LS11 8 DT; UK LS11 8 DT
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 15223790
• Report Number: 1818910-2022-15777
• Device Sequence Number: 12170719
• Product Code: JWH
• UDI-Device Identifier: 10603295475170
• UDI-Public: 10603295475170
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/15/2022

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 Model Number: 1512-14-080
• Device Catalogue Number: 151214080
• Device Lot Number: D21022849
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/07/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/12/2022
• Initial Report FDA Received Date: 08/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/13/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Female