MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US GLOBAL ADVANTAGE STEM 10 MM; GLOBAL ADVANTAGE IMPLANT : SHOULDER HUMERAL STEMS

Model Number	1137-10-000
Medical Device Problem Code	Loss of or Failure to Bond (1068)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/17/2021
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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.
Additional 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.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 : 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: GLOBAL ADVANTAGE STEM 10 MM
• Common Device Name: GLOBAL ADVANTAGE IMPLANT : SHOULDER HUMERAL STEMS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 11405243
• Report Number: 1818910-2021-04263
• Device Sequence Number: 11895138
• Product Code: KWS
• UDI-Device Identifier: 10603295007111
• UDI-Public: 10603295007111
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K992065
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/16/2021

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 Model Number: 1137-10-000
• Device Catalogue Number: 113710000
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/17/2021
• Supplement Date Received by Manufacturer: 04/27/2021
• Initial Report FDA Received Date: 03/03/2021
• Supplement Report FDA Received Date: 04/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 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
• Outcome Attributed to Adverse Event: Required Intervention