MAUDE Adverse Event Report: DEPUY IRELAND 9616671 GLOBAL UNITE BODY SZ 12 +5; GLOBAL UNITE IMPLANTS : SHOULDER HUMERAL STEM ACCESSORY

Catalog Number	110040120
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); No Code Available (3191)
Date of Event	10/01/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint #: (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Concomitant med products: global unite head 48x18 std shoulder humeral head component.Global unite body sz 12 +5 shoulder humeral stem component.(b)(4).
Event or Problem Description
Revision shoulder replacement: (b)(6), (b)(6), (b)(6) 2018.Original case: (b)(6) 2017, (b)(6), surgeon: (b)(6).Reason for revision: pain and lack of function.Conversion of unite fracture stem to delta extend.Removed fracture body and head, and converted to standard delta epi 1 left, 38/3 high mobility standard metaglene, and 38 eccentric head.Was extremely hard to reduce, mainly as original case looked like it had been cemented too high.Female patient initials (b)(6), aged (b)(6), dob: (b)(6).
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.A worldwide lot specific complaint database search, or device history record (dhr) review, was not possible because the required lot code(s) was not provided.The investigation could not draw any conclusions regarding the reported event.Based on the inability to determine a root cause, the need for corrective action was not indicated.Device history lot: null.Device history batch: null.Device history review: null.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 +5
• Common Device Name: GLOBAL UNITE IMPLANTS : SHOULDER HUMERAL STEM ACCESSORY
• Manufacturer (Section D): DEPUY IRELAND 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 8006281
• Report Number: 1818910-2018-73548
• Device Sequence Number: 16469101
• Product Code: KWS
• UDI-Device Identifier: 10603295004462
• UDI-Public: 10603295004462
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/01/2018

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: 110040120
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/01/2018
• Supplement Date Received by Manufacturer: 11/22/2018
• Initial Report FDA Received Date: 10/25/2018
• Supplement Report FDA Received Date: 11/23/2018
• 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: 72 YR