MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. UNKNOWN TRILOCK ANTERIOR HIP STEM INSERTER; HIP INSTRUMENT/TRIAL

Catalog Number UNK-HIP

Device Problem Break (1069)

Patient Problem No Information (3190)

Event Date 07/08/2015

Event Type  malfunction  

Event Description

Anterior hip stem inserter tip broke off during stem insertion.

Manufacturer Narrative

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.Depuy synthes has been informed that the catalog number and lot number is not available.

Manufacturer Narrative

Previous investigations, including evaluations by a depuy material scientist has determined that user error is the most likely root cause.Manufacturing or material error was not identified.It is however recognized that improvements are possible to alleviate this issue even if not used properly.(b)(4) was approved and completed on january 15, 2010, which includes improvements to bolster the durability of this instrument.Health hazard evaluations (b)(4) in march 2009 and (b)(4) in january 2011 were held to determine the risk involved with the tip of a modular stem inserter breaking off during surgery.The hhe from 2009 and again in 2011 concluded that no field action was required.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: UNKNOWN TRILOCK ANTERIOR HIP STEM INSERTER
• Type of Device: HIP INSTRUMENT/TRIAL
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC.; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer Contact: steve dowell ; 700 orthopaedic drive; warsaw, IN 46581 ; 5743714918
• MDR Report Key: 4946327
• MDR Text Key: 6192478
• Report Number: 1818910-2015-26704
• Device Sequence Number: 1
• Product Code: LXH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Distributor,distributor,health prof
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/08/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK-HIP
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/09/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Age: 59 YR
• Patient Weight: 136