MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US GLOBAL SHD END PEG GLEN 52; GLENOID (KEELED AND 5-PEGGED) IMPLANT : SHOULDER GLENOID

Model Number 1137-87-025

Device Problem Loss of or Failure to Bond (1068)

Patient Problem Insufficient Information (4580)

Event Date 02/17/2021

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

Revision of anatomic shoulder to reverse shoulder - aseptic loosening of anatomic shoulder components, implants removed and reverse unable to be completed, therefore, reverse stem with cta head was implanted.The head was removed with the removal tool, then both the stem and the glenoid were able to be removed with little to no effort - were more just sitting in the humeral canal and glenoid bone rather than attached to these interfaces.

Event Description

Additional information received indicated that the affected side was the right shoulder.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.A worldwide complaint database search found no other related reported incidents against the provided product code/lot number combination since release for distribution.Based on previous investigations, this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications.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 : no anomalies or deviations were found during the review.

• Brand Name: GLOBAL SHD END PEG GLEN 52
• Type of Device: GLENOID (KEELED AND 5-PEGGED) IMPLANT : SHOULDER GLENOID
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 11405242
• MDR Text Key: 234466101
• Report Number: 1818910-2021-04262
• Device Sequence Number: 1
• Product Code: KWT
• UDI-Device Identifier: 10603295007289
• UDI-Public: 10603295007289
• 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: 02/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/03/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1137-87-025
• Device Catalogue Number: 113787025
• Device Lot Number: XB4KN1
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: GLOBAL ADVANTAGE ECC HD 52X21; GLOBAL ADVANTAGE STEM 10 MM; GLOBAL SHD END PEG GLEN 52; GLOBAL ADVANTAGE ECC HD 52X21; GLOBAL ADVANTAGE STEM 10 MM; GLOBAL SHD END PEG GLEN 52
• Patient Outcome(s): Required Intervention