MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 ARTIC/EZE TR BALL GRVD 32+1; HIP INSTRUMENTS : FEMORAL TRIALS

Catalog Number 253091000

Device Problem Disassembly (1168)

Patient Problems Foreign Body In Patient (2687); Not Applicable (3189)

Event Date 01/11/2018

Event Type  Injury  

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

Der states that the surgeon attempted to reduce the hip, while trailing a 32 + 1 head and a standard neck.The hip did not reduce, and the head trial popped off.The trial head could be felt within the pelvis of the patient.Surgeon attempted several times to retrieve the trial head.Surgeon decided to finish the surgery, leave the trial head within the pelvis, and take a ct at a later time.Surgery was extended for 30 mins.

Manufacturer Narrative

Investigation summary: the instrument associated with this report was not returned.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, a follow-up medwatch will be filed as appropriate. .

• Brand Name: ARTIC/EZE TR BALL GRVD 32+1
• Type of Device: HIP INSTRUMENTS : FEMORAL TRIALS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910 ; 700 orthopaedic drive; warsaw IN 46582 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910 ; 700 orthopaedic drive; warsaw IN 46582 0988
• Manufacturer Contact: chad gibson ; 700 orthopaedic drive; warsaw, IN 46582-0988 ; 5743725905
• MDR Report Key: 7444336
• MDR Text Key: 105958189
• Report Number: 1818910-2018-57826
• Device Sequence Number: 1
• Product Code: LXH
• UDI-Device Identifier: 10603295128991
• UDI-Public: 10603295128991
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date: 03/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 253091000
• Device Lot Number: HT0604
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/22/2018
• Date Device Manufactured: 06/15/2004
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 70 YR