MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 SROM DIST STEM TRIAL 11 STD; HIP INSTRUMENTS : FEMORAL TRIALS

Catalog Number	257611100
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	08/22/2018
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
At trailing phase, surgeon went to use trail as prepared for.This was the 16x11 trial, with a 36 standard neck.These two are joined with a screw and thread, and interlock with teeth on both components.To change the version, the neck can be rotated, and then locked onto the stem.However this locking mechanism was broken, causing significant problems and delay to surgery as he could not trail the stem version.To complete the procedure, the surgeon had to open the definitive implant and approximate ideal version of the stem.Surgeon indicated this is not the first time it has happened.A 30 minute delay to the procedure.
Additional Manufacturer Narrative
Product complaint # pc-(b)(4).Investigation summary no device was received.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 will be filed as appropriate.
Additional Manufacturer Narrative
Product complaint #: (b)(4).Investigation summary: no device was received.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: SROM DIST STEM TRIAL 11 STD
• Common Device Name: HIP INSTRUMENTS : FEMORAL TRIALS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 7880372
• Report Number: 1818910-2018-69466
• Device Sequence Number: 1819274
• Product Code: LXH
• UDI-Device Identifier: 10603295146063
• UDI-Public: 10603295146063
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: NI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/22/2018

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: 257611100
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/22/2018
• Supplement Date Received by Manufacturer: 11/09/2018; 12/18/2018
• Initial Report FDA Received Date: 09/17/2018
• Supplement Report FDA Received Date: 11/09/2018; 01/01/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1