MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 AB EXTRACTOR BODY 52MM; HIP INSTRUMENTS : EXTRACTION INSTRUMENTS

Catalog Number 221700052

Device Problem Incomplete or Inadequate Connection (4037)

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

Event Date 06/27/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

I covered a hip revision case yesterday afternoon at (b)(6) hospital where one of the instruments used to remove the ceramic liner failed to work and as a result the surgeon had to revise the entire cup rather exchanging the liner only.The instrument is size 52mm pinnacle ab liner extractor (see picture below).It was from a loan kit booked under reference: (b)(4).

Manufacturer Narrative

Product complaint #: (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

There was a 30-minute surgical delay.

Manufacturer Narrative

Product complaint #: (b)(4).Investigation summary: examination of the returned instrument cannot confirm 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.

Manufacturer Narrative

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

• Brand Name: AB EXTRACTOR BODY 52MM
• Type of Device: HIP INSTRUMENTS : EXTRACTION INSTRUMENTS
• 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: 7714504
• MDR Text Key: 114935113
• Report Number: 1818910-2018-65105
• Device Sequence Number: 1
• Product Code: HWB
• UDI-Device Identifier: 10603295097280
• UDI-Public: 10603295097280
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 06/27/2018

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: 221700052
• Device Lot Number: AH0804
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/16/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/27/2018
• Initial Date FDA Received: 07/24/2018
• Supplement Dates Manufacturer Received: 08/01/2018; 08/24/2018; 08/24/2018
• Supplement Dates FDA Received: 08/08/2018; 08/27/2018; 09/13/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/15/2004
• 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