MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNK SHOULDER GLENOID GLOBAL; SHOULDER GLENOID

Catalog Number UNK SHOULDER GLENOID GLOBAL

Device Problem Off-Label Use (1494)

Patient Problem Pain (1994)

Event Date 02/08/2021

Event Type  Injury  

Manufacturer Narrative

Product complaint # (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 shoulder was revised to address pain, possible aseptic loosening.Both, a cemented non-porous humeral stem and glenoid component were found to not have been cemented in place.No surgical delay.Doi: (b)(6) 2008.Dor: (b)(6) 2021; left shoulder.

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 device history record (dhr) review, was not possible because the required lot number was not provided.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Device history lot : the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).Where the lot code was provided, a manufacturing records evaluation (mre) was not performed.

• Brand Name: UNK SHOULDER GLENOID GLOBAL
• Type of Device: SHOULDER GLENOID
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 11365833
• MDR Text Key: 233073957
• Report Number: 1818910-2021-03640
• 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: 02/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK SHOULDER GLENOID GLOBAL
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNK SHOULDER GLENOID GLOBAL; UNK SHOULDER HUMERAL HEAD GLOBAL; UNK SHOULDER HUMERAL STEM GLOBAL; UNK SHOULDER GLENOID GLOBAL; UNK SHOULDER HUMERAL HEAD GLOBAL; UNK SHOULDER HUMERAL STEM GLOBAL
• Patient Outcome(s): Required Intervention
• Patient Age: 64 YR
• Patient Weight: 81