MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 GLOBAL UNITE HEAD 52X18 ECC; GLOBAL UNITE IMPLANTS : HUMERAL TRIALS

Model Number 1100-52-610

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

Patient Problems Pain (1994); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 11/12/2020

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

The patient was revised to address pain due to infection.Doi: (b)(6) 2020, dor: (b)(6) 2020, right 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 at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.Device history lot: no lot information available.

• Brand Name: GLOBAL UNITE HEAD 52X18 ECC
• Type of Device: GLOBAL UNITE IMPLANTS : HUMERAL TRIALS
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 10906036
• MDR Text Key: 218513735
• Report Number: 1818910-2020-25510
• Device Sequence Number: 1
• Product Code: HSD
• UDI-Device Identifier: 10603295004738
• UDI-Public: 10603295004738
• Combination Product (y/n): N
• PMA/PMN Number: K101996
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 11/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/25/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 1100-52-610
• Device Catalogue Number: 110052610
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CROSSLINK ANCHOR PG GLENOID 48; GLBL UNITE ANT BODY 135 SZ 12; GLOBAL UNITE HEAD 52X18 ECC; GLOBAL UNITE STD STEM SZ 12
• Patient Outcome(s): Required Intervention
• Patient Age: 62 YR