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

Catalog Number 121722056

Device Problem Failure to Disconnect (2541)

Patient Problem No Information (3190)

Event Date 11/24/2015

Event Type  malfunction  

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

The surgeon could not remove the inserter from the cup after impacting the cup although the connection between all the trial cups and the inserter had been checked before the surgery.It was reported that they could remove the devices in the pre-op inspection even though the devices were tightened.The surgeon replaced the reported cup with a multi hole cup and completed the surgery with a 25-minute delay.There was no harm to the patient.

Manufacturer Narrative

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

Manufacturer Narrative

Conclusion and justification status: the complaint states during tha for oa on (b)(6), the surgeon could not remove the inserter from the cup after impacting the cup although the connection between all the trial cups and the inserter had been checked before the surgery.It was reported that they could remove the devices in the pre-op inspection even though the devices were tightened.The surgeon replaced the reported cup with a multi hole cup and completed the surgery with a 25-minute delay.There was no harm to the patient.The investigation confirmed that the end part of the macs inserter was stuck in the returned cup.In an attempt to solve the issue of the cup sticking to the adaptor the testing of prototype designs created under (b)(4) took place, and research and development report l740 was created.The testing showed that the prototype designs reduced the frequency of locking between the cup and adaptor during testing, but did not eliminate the fundamental cause of sticking.Other designs of introducers have the same issue of sticking.The complaint shall be closed with a justified conclusion; entered into the complaints database and monitored through trend analysis.If further information is received the complaint shall be reopened and investigated further.Depuy still 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.

• 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 9616671; loughbeg, ringaskiddy co.; cork, muenster ; EI
• Manufacturer Contact: chad gibson ; 700 orthopaedic drive; warsaw, IN 46581 ; 5743725905
• MDR Report Key: 5266905
• MDR Text Key: 32668097
• Report Number: 1818910-2015-36640
• Device Sequence Number: 1
• Product Code: MRA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PP070026
• 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,Followup
• Report Date: 11/24/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/04/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2012
• Device Catalogue Number: 121722056
• Device Lot Number: 7829573
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/07/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/14/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/10/2014
• 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