MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 UNK SHOULDER HUMERAL CUP

Catalog Number UNK SHOULDER HUMERAL CUP DELTA

Device Problem Naturally Worn (2988)

Patient Problem Insufficient Information (4580)

Event Date 09/08/2021

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.A worldwide lot specific complaint database search, or manufacturing record evaluation, was not possible as the required lot number was not provided.The information received will be retained for trend analysis, post market surveillance, or other events within the quality system.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 poly inlay showed abrasion on the delta xtend cup.No patient consequence.No surgical delay.

Event Description

A.Date of implantation (b)(6) 2021.B.When is the planned revision date? none planned, not necessary.C.Affected side: unknown.D.Was there any adverse consequences that affected the patient because of the reported event? no.E.It was indicated that, "article code of the explanted product is similar, but not correct, because product code and lot are not available anymore" and a product name dxtend stand pe cup d42 +3mm were entered.Can you please clarify that the product involved is a dxtend stand pe cup but the product and lot codes are unknown? correct f.Can you provide the exact event date? this complaint was received on sept.09, 2021.(b)(6) 2021.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.A worldwide lot specific complaint database search, or manufacturing record evaluation, was not possible as the required lot number was not provided.The information received will be retained for trend analysis, post market surveillance, or other events within the quality system.Device history lot : a manufacturing record evaluation (mre), was not possible because the required lot code was not provided.

• Brand Name: UNK SHOULDER HUMERAL CUP
• Type of Device: SHOULDER HUMERAL CUP
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 12526500
• MDR Text Key: 273137920
• Report Number: 1818910-2021-21026
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 09/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK SHOULDER HUMERAL CUP DELTA
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1