MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 GLOBAL UNITE HEAD 44X18 ECC

Catalog Number 110044610

Device Problem Disassembly (1168)

Patient Problem Pain (1994)

Event Date 11/10/2017

Event Type  Injury  

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

Der states that the head disassociated from humeral head causing pain to left shoulder.Doi: unknown.Dor: (b)(6) 2017.Left shoulder.

Manufacturer Narrative

Product complaint: (b)(4).Investigation summary: no device associated with this report was received for examination.Depuy synthes considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation may 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: GLOBAL UNITE HEAD 44X18 ECC
• Type of Device: GLOBAL UNITE HEAD
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• 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: 7099972
• MDR Text Key: 94248362
• Report Number: 1818910-2017-51096
• Device Sequence Number: 1
• Product Code: HSD
• UDI-Device Identifier: 10603295004554
• UDI-Public: 10603295004554
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K101996
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 11/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 110044610
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/20/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention