MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 TRIAL CORAIL REVISION STEM 16; HIP INSTRUMENT/TRIAL

Catalog Number	L98516
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Information (3190)
Date of Event	06/22/2017
Type of Reportable Event	Malfunction
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 sales rep reports that during a revision surgery, the surgeon had a problem on his ancillary corail revision on deposit, on the trial stem size 16.The surgeon had a very odd feel and trying a corail stem of the same size, it turned out that the metaphyseal filling was not identical.He also compared the trial stem size 16 with an other trial stem size 16 from a loan kit.They did not have the same dimensions.
Additional Manufacturer Narrative
Depuy considers the investigation closed at this time.Should the 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.
Event or Problem Description
Delay in surgery is about 10 minutes.Reason for revision is mechanical issue.
Additional Manufacturer Narrative
The complaint description states that the metaphyseal filling and dimensions were not identical between the sz 16 corail revision stem and the trial stem.The device associated with this report was received for examination.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.
Additional Manufacturer Narrative
Additional narrative: depuy considers the investigation closed at this time.Should the 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: TRIAL CORAIL REVISION STEM 16
• Common Device Name: HIP INSTRUMENT/TRIAL
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; bp 256; warsaw IN 46582
• MDR Report Key: 6732322
• Report Number: 1818910-2017-21515
• Device Sequence Number: 817100
• Product Code: LXH
• UDI-Device Identifier: 10603295262640
• UDI-Public: 10603295262640
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 06/22/2017

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: L98516
• Device Lot Number: SF0874518
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/08/2017
• Initial Date Received by Manufacturer: 06/22/2017
• Supplement Date Received by Manufacturer: 07/26/2017; 08/08/2017; 01/11/2018
• Initial Report FDA Received Date: 07/21/2017
• Supplement Report FDA Received Date: 08/15/2017; 09/06/2017; 01/19/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1