MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 UNK SHOULDER GLENOSPHERE DELTA XTEND

Catalog Number UNK SHOULDER GLENOSPHERE DELTA

Device Problems Fracture (1260); Difficult to Insert (1316)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/28/2024

Event Type  malfunction  

Manufacturer Narrative

Product complaint: (b)(4).D4: the device catalog number is unknown; therefore, udi is unavailable.This report is being submitted pursuant to the provisions of 21 cfr, part 803 (and/or part 4, as applicable).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, or its employees that the report constitutes an admission that the product, depuy synthes, 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.

Event Description

Glenosphere would not screw in to metaglene.Numerous attempts made, new glenosphere opened and still same issue which then ended up wrecking the thread of the glenospheres.Ended up taking out metaglene and inserting a new one and problem was resolved.So original metaglene must¿ve had a threading issue.Was surgery delayed due to the reported event? yes.Action taken when event occurred? open new metaglene.

Manufacturer Narrative

Product complaint (b)(4).Investigation summary: according to the information received.Glenosphere would not screw in to metaglene.Numerous attempts made.New glenosphere opened and still same issue.Which, then ended up wrecking the thread of the glenospheres.Ended up taking out metaglene and inserting a new one and problem was resolved.So original metaglene must¿ve had a threading issue.The product was not returned to depuy synthes.However, photos were provided for review.The photographs attached were reviewed.However, they do not represent the reported complaint condition.Therefore, the investigation could not draw any conclusions about the reported event, due to the insufficient evidence provided.Only it was observed, the mating device.As the device was not returned, an as-received condition could not be assessed.And a dimensional inspection and document/specification review were not completed.The overall complaint was unconfirmed, as the photographs provided are not representative of the reported complaint condition.Based on the investigation findings, it has been determined, that no corrective and/or preventative action is proposed.There is no indication, that a design or manufacturing issue has caused the complaint condition.As part of depuy synthes quality process, all devices are manufactured, inspected and released to approved specifications.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot : a manufacturing records evaluation (mre) was not performed, as no lot number was provided for this device.

• Brand Name: UNK SHOULDER GLENOSPHERE DELTA XTEND
• Type of Device: SHOULDER GLENOSPHERE
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): JTE WARSAW MFG SITE; 700 orthopaedic drive; warsaw IN
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 19114535
• MDR Text Key: 341011025
• Report Number: 1818910-2024-08347
• Device Sequence Number: 1
• Product Code: KWS
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/16/2024

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 Catalogue Number: UNK SHOULDER GLENOSPHERE DELTA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/27/2024
• Initial Date FDA Received: 04/16/2024
• Supplement Dates Manufacturer Received: 05/21/2024
• Supplement Dates FDA Received: 05/22/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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