MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 GL UNITE ANT BDY 135 SZ 06 08; GLOBAL UNITE IMPLANTS : SHOULDER HUMERAL STEM ACCESSORY

Catalog Number 110020000

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); No Code Available (3191)

Event Date 11/12/2019

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

Patient was revised to address pain.Rotator cuff failure and conversion to a rtsa done.Doi: (b)(6) 2015, dor: (b)(6) 2019, unknown 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: GL UNITE ANT BDY 135 SZ 06 08
• Type of Device: GLOBAL UNITE IMPLANTS : SHOULDER HUMERAL STEM ACCESSORY
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): DEPUY IRELAND 9616671; loughbeg, ringaskiddy co.; cork ; EI
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 9425959
• MDR Text Key: 173270568
• Report Number: 1818910-2019-121382
• Device Sequence Number: 1
• Product Code: HSD
• UDI-Device Identifier: 10603295433217
• UDI-Public: 10603295433217
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K133834
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/12/2019

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: 110020000
• Device Lot Number: 7967799
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/12/2019
• Initial Date FDA Received: 12/06/2019
• Supplement Dates Manufacturer Received: 01/07/2020
• Supplement Dates FDA Received: 01/08/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/15/2014
• 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