MAUDE Adverse Event Report: DEPUY IRELAND ¿ REG. # 9616671 GLOBAL UNITE BODY SZ 12 0; SHOULDER HUMERAL STEM/EPIPHYSIS

Catalog Number 110040110

Device Problem Disassembly (1168)

Patient Problem No Information (3190)

Event Date 03/28/2017

Event Type  Injury  

Manufacturer Narrative

This complaint is under investigation.Depuy will notify the fda of the results of the 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

Sometime in the weeks post op, the global unite body and head became uncoupled from the stem and broke away from humeral shaft.

Manufacturer Narrative

Revision hemiarthroplasty for a proximal humerus fracture was performed on (b)(6) 2017 at (b)(6) hospital due to refracture of humeral shaft.Primary implant date (b)(6) 2017.Event occured post op.The rep was at the case for implantation and the correct surgical technique was used by surgeon.Sometime in the weeks after post op, the global unite body and head became uncoupled from the stem and broke away from humeral shaft.Unsure as to whether the body and stem separating caused the bone to also separate.Implant not available for return - hospital unwilling to release.Waiting for results post revision surgery.No supporting documents available.No device associated with this report was received for examination.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 ¿ REG. # 9616671; loughbeg, ringaskiddy co.; cork, munster ; EI
• Manufacturer (Section G): DEPUY IRELAND ¿ REG. # 9616671; loughbeg, ringaskiddy co.; cork, munster ; EI
• Manufacturer Contact: chad gibson ; 700 orthopaedic drive; warsaw, IN 46581 ; 5743725905
• MDR Report Key: 6522487
• MDR Text Key: 73726836
• Report Number: 1818910-2017-17047
• Device Sequence Number: 1
• Product Code: HSD
• 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: foreign,health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 03/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 8056149
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/29/2017
• Initial Date FDA Received: 04/26/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/09/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/17/2015
• 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