MAUDE Adverse Event Report: DEPUY IRELAND 9616671 PINNACLE SECTOR II CUP 56MM; HIP ACETABULAR CUP

Catalog Number 121722056

Device Problem Malposition of Device (2616)

Patient Problem No Code Available (3191)

Event Date 07/19/2016

Event Type  Injury  

Manufacturer Narrative

This complaint is still under investigation.Depuy will notify the fda of the results of this investigation once it has been completed.(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

Revised due to squeaking and impingement between the ceramic femoral head and ceramic liner.The surgeon stated that the anatomy of the patient was different when they stood up compared to when they were lying on their side intraoperatively therefore the cup was malpositioned.

Manufacturer Narrative

Depuy considers the investigation closed.Should additional information be received the investigation will be reopened.

• Brand Name: PINNACLE SECTOR II CUP 56MM
• Type of Device: HIP ACETABULAR CUP
• Manufacturer (Section D): DEPUY IRELAND 9616671; loughbeg, ringaskiddy co.; cork, muenster ; EI
• Manufacturer (Section G): DEPUY IRELAND; loughbeg, ringaskiddy co.; cork ; EI
• Manufacturer Contact: chad gibson ; 700 orthopaedic drive; warsaw, IN 46581 ; 5743725905
• MDR Report Key: 5843458
• MDR Text Key: 51047030
• Report Number: 1818910-2016-24420
• Device Sequence Number: 1
• Product Code: MRA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P070026
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 07/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2023
• Device Catalogue Number: 121722056
• Device Lot Number: 5661744
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/06/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/30/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 60 YR