MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. TISSUE SPARING FEM CORE CASE 1; HIP INSTRUMENT/TRIAL

Catalog Number 259807390

Device Problem Delamination (2904)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/09/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).This complaint is still under investigation.Depuy will notify the fda of the results of this investigation once it has been completed.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

The trays are delaminating.

Manufacturer Narrative

If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.(b)(4).This complaint is still under investigation.Depuy will notify the fda of the results of this investigation once it has been completed.

Manufacturer Narrative

Examination of the returned instrument case confirms bracket delamination after more than eight years in service.The investigation did not identify any problem related to design, material or manufacture that would contribute to the reported issue.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.

• Brand Name: TISSUE SPARING FEM CORE CASE 1
• Type of Device: HIP INSTRUMENT/TRIAL
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC.; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC.; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer Contact: chad gibson ; 700 orthopaedic drive; warsaw, IN 46581 ; 5743725905
• MDR Report Key: 6367602
• MDR Text Key: 68597232
• Report Number: 1818910-2017-13711
• Device Sequence Number: 1
• Product Code: FSM
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 02/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 259807390
• Device Lot Number: CF6L44
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/22/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/05/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/25/2008
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1