MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US GLOBAL SHD END PEG GLEN 44; GLENOID (KEELED AND 5-PEGGED) IMPLANT : SHOULDER GLENOID

Catalog Number	113785025
Medical Device Problem Code	Loss of or Failure to Bond (1068)
Health Effect - Clinical Codes	Pain (1994); Unspecified Tissue Injury (4559)
Date of Event	03/12/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that there was revision tsr to rsr due to cuff failure and glenoid loosening.The patient has had a long-term good result from her anatomic total shoulder replacements.In the last couple of years, the right side has become painful, and it appears that her rotator cuff has given way, as suggested by the superior migration of the humeral component.
Additional Manufacturer Narrative
Product complaint # (b)(4).Depuy orthopaedics is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy orthopaedics has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy orthopaedics or its employees that the report constitutes an admission that the device, depuy orthopaedics, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H11 additional narrative: d4: udi: as the lot number for the device involved in the event was not provided, the full udi is currently not available.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Additional Manufacturer Narrative
Product complaint # (b)(4) investigation summary revision tsr to rsr due to cuff failure and glenoid loosening the product was not returned to j&j medtech orthopaedics; however, a photo was provided for review.See attachment (b)(4).The photo investigation revealed that the global shd end peg glen 44 had what appears to be extraction marks and displays signs on the surface consistent for a glenoid that has been implanted.However, there is nothing indicative of a device nonconformance, 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 not confirmed as the observed condition of the global shd end peg glen 44 would not have contributed to the complained device issue.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 reported complaint condition.As part of j&j medtech orthopaedics 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 the device lot number is unknown; therefore, a device history review could not be performed.If the lot/serial number becomes available, the record will be re-assessed.

• Brand Name: GLOBAL SHD END PEG GLEN 44
• Common Device Name: GLENOID (KEELED AND 5-PEGGED) IMPLANT : SHOULDER GLENOID
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): JTE WARSAW MFG SITE; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer Contact: elba bello ; 700 orthopaedic dr.; warsaw, IN 46581 ; 9083863534
• MDR Report Key: 21772290
• Report Number: 1818910-2025-05102
• Device Sequence Number: 9658352
• Product Code: KWT
• UDI-Device Identifier: 10603295007241
• UDI-Public: (01)10603295007241
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K914000
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 113785025
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/12/2025
• Supplement Date Received by Manufacturer: 05/05/2025
• Initial Report FDA Received Date: 04/04/2025
• Supplement Report FDA Received Date: 05/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female