MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US TRIAL SPACER 12/14 -3; HIP INSTRUMENTS : FEMORAL TRIALS

Catalog Number 203816000

Device Problem Device Damaged by Another Device (2915)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/30/2018

Event Type  malfunction  

Manufacturer Narrative

Product complaint (b)(4) investigation summary: examination of the returned instrument 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.

Event Description

It was reported that the curved bipolar handle will not accept trials / -3 uni polar disc beimenduring trial reduction.

• Brand Name: TRIAL SPACER 12/14 -3
• Type of Device: HIP INSTRUMENTS : FEMORAL TRIALS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer Contact: chad gibson ; 700 orthopaedic drive; warsaw, IN 46581-0988 ; 5743725905
• MDR Report Key: 7949544
• MDR Text Key: 123203668
• Report Number: 1818910-2018-71899
• Device Sequence Number: 1
• Product Code: LXH
• UDI-Device Identifier: 10603295084327
• UDI-Public: 10603295084327
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/01/2018

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
• Device Operator: Health Professional
• Device Catalogue Number: 203816000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/12/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/01/2018
• Initial Date FDA Received: 10/09/2018
• Was Device Evaluated by Manufacturer?: Yes
• 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