MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 PIN TRL +4 NEUT 580DX36ID; HIP INSTRUMENT/TRIAL

Catalog Number 221836458

Device Problems Cut In Material (2454); Material Integrity Problem (2978)

Patient Problem No Information (3190)

Event Date 09/14/2017

Event Type  malfunction  

Manufacturer Narrative

If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

It was reported that the liners has scaring inside the diameter.On (b)(6) 2017: evaluation of the returned instruments found deep gouges with pieces of material missing.(b)(6).

Manufacturer Narrative

Additional narrative: examination of the returned instruments confirmed the complaint.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.

• Brand Name: PIN TRL +4 NEUT 580DX36ID
• Type of Device: HIP INSTRUMENT/TRIAL
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer Contact: chad gibson ; 700 orthopaedic drive; warsaw, IN 46581 ; 5743725905
• MDR Report Key: 7024699
• MDR Text Key: 92321030
• Report Number: 1818910-2017-28824
• Device Sequence Number: 1
• Product Code: LXH
• UDI-Device Identifier: 10603295101383
• UDI-Public: 10603295101383
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 221836458
• Device Lot Number: KA1106
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/22/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/13/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/15/2006
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1