MAUDE Adverse Event Report: DEPUY IRELAND GLOBAL UNITE BODY SZ 12 0; SHOULDER HUMERAL STEM/EPIPHYSIS

Catalog Number 110040110

Device Problem Disassembly (1168)

Patient Problems Pain (1994); No Code Available (3191)

Event Date 05/01/2017

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

The patient had revision of the global unite head that was no longer sitting flush.It was also stated that the patient reported pain.

Manufacturer Narrative

No device associated with this report was received for examination.A worldwide complaint database search found no other reported incident(s) against the provided product/lot combination(s) since release for distribution.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.

• Brand Name: GLOBAL UNITE BODY SZ 12 0
• Type of Device: SHOULDER HUMERAL STEM/EPIPHYSIS
• Manufacturer (Section D): DEPUY IRELAND; loughbeg, ringaskiddy co.; cork IN ; EI
• Manufacturer (Section G): DEPUY IRELAND; loughbeg, ringaskiddy co.; cork IN ; EI
• Manufacturer Contact: chad gibson ; 700 orthopaedic drive; warsaw, IN 46581 ; 5743725905
• MDR Report Key: 6594856
• MDR Text Key: 76075292
• Report Number: 1818910-2017-18729
• Device Sequence Number: 1
• Product Code: HSD
• Combination Product (y/n): N
• PMA/PMN Number: K101996
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Type of Report: Initial,Followup
• Report Date: 05/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 110040110
• Device Lot Number: 7489919
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/11/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/24/2013
• 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: 71 YR