MAUDE Adverse Event Report: DEPUY IRELAND 9616671 GLOBAL UNITE HEAD 48X18 STD; GLOBAL UNITE IMPLANTS : HUMERAL TRIALS

Catalog Number	110048510
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Pain (1994)
Date of Event	02/15/2018
Type of Reportable Event	Serious Injury
Additional 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 or Problem Description
It was reported that the reported device was used during the prosthetic arthroplasty of shoulder joint on (b)(6) 2017 due to a shoulder fracture.The patient was a (b)(6)-year-old male.His right shoulder surgery was performed.Post-surgically, on (b)(6) 2018, the patient reported having a shoulder pain.The x-ray images were taken.It was found that the head of the reported device had been dislodged.On (b)(6) 2018, the reoperation was performed.The head and color were removed, and the head40x15 was replaced.It was brand new and the first use when the issue occurred.There was no delay in surgery and no harm to the patient.
Additional Manufacturer Narrative
(b)(4).
Additional Manufacturer Narrative
Investigation summary: (b)(4).No device associated with this report was received for examination.The investigation could not draw any conclusions regarding the reported event.Re-open upon receipt of the device evaluation of the returned device finds evidence of implant disassociation.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 HEAD 48X18 STD
• Common Device Name: GLOBAL UNITE IMPLANTS : HUMERAL TRIALS
• Manufacturer (Section D): DEPUY IRELAND 9616671; loughbeg, ringaskiddy co.; cork ; EI
• MDR Report Key: 7326610
• Report Number: 1818910-2018-54809
• Device Sequence Number: 19218519
• Product Code: HSD
• UDI-Device Identifier: 10603295004585
• UDI-Public: 10603295004585
• Combination Product (Y/N): N
• PMA/510(K) Number: K101996
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/15/2018

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
• Operator of Device: Health Professional
• Device Catalogue Number: 110048510
• Device Lot Number: C80598
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/05/2018
• Initial Date Received by Manufacturer: 02/15/2018
• Supplement Date Received by Manufacturer: 03/16/2018; 08/30/2018
• Initial Report FDA Received Date: 03/09/2018
• Supplement Report FDA Received Date: 04/02/2018; 09/24/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 68 YR