MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 GLBL UNITE ANT BODY 128 SZ 12; GLOBAL UNITE IMPLANTS : SHOULDER HUMERAL STEM ACCESSORY

Model Number 1100-40-010

Device Problem Difficult to Remove (1528)

Patient Problem Insufficient Information (4580)

Event Date 06/09/2021

Event Type  malfunction  

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

It was reported that the patient had a revision surgery plan to convert a global unite proximal body to an epiphysis for a reverse shoulder arthroplasty.Surgeon was unable to "unscrew" the proximal body from the stem.The stem/body construct was implanted in the patient.The surgeon ended up removing the entire stem/body construct.Two hex screwdrivers were broken trying to remove screw.A surgical delay of 30 minutes was also reported.Doi: unknown; dor: (b)(6) 2021; right shoulder.

Manufacturer Narrative

Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• Brand Name: GLBL UNITE ANT BODY 128 SZ 12
• Type of Device: GLOBAL UNITE IMPLANTS : SHOULDER HUMERAL STEM ACCESSORY
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 12065517
• MDR Text Key: 258388547
• Report Number: 1818910-2021-13564
• Device Sequence Number: 1
• Product Code: HSD
• UDI-Device Identifier: 10603295004424
• UDI-Public: 10603295004424
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 06/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1100-40-010
• Device Catalogue Number: 110040010
• Device Lot Number: 8292578
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/23/2021
• Initial Date Manufacturer Received: 06/09/2021
• Initial Date FDA Received: 06/25/2021
• Supplement Dates Manufacturer Received: 06/23/2021; 08/02/2021
• Supplement Dates FDA Received: 07/07/2021; 08/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 66 YR