MAUDE Adverse Event Report: DEPUY IRELAND 9616671 UNKNOWN SHOULDER METAGLENE

Catalog Number UNK SHOULDER METAGLENE

Device Problem Difficult to Insert (1316)

Patient Problem No Code Available (3191)

Event Date 10/28/2020

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

Glenosphere would not attach to metaglene, after repeated efforts threads were damaged and a new implant was used.

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.Device history review: no lot information available.

• Brand Name: UNKNOWN SHOULDER METAGLENE
• Type of Device: SHOULDER METAGLENE
• Manufacturer (Section D): DEPUY IRELAND 9616671; loughbeg, ringaskiddy co.; cork ; EI
• MDR Report Key: 10830679
• MDR Text Key: 217669480
• Report Number: 1818910-2020-24384
• Device Sequence Number: 1
• Product Code: HSD
• 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
• Report Date: 10/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/12/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK SHOULDER METAGLENE
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: XTND GLENO ECC D38MM +2MM
• Patient Age: 66 YR