MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US GLOBAL SHD END FIN GLEN 40XS; GLOBAL ADVANTAGE IMPLANT : SHOULDER HUMERAL HEADS

Model Number	1128-40-000
Medical Device Problem Codes	Loss of or Failure to Bond (1068); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	06/10/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(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
Patient was revised due to mechanical loosening and rotator cuff tear.Lot number is not legible on the glenoid component.No other information is available.Doi: unknown; dor: (b)(6) 2020; right shoulder.
Additional Manufacturer Narrative
Product complaint#: (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.H10 additional narrative: corrected: d4 (catalog, udi).
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.Photographs and x-rays were returned for review and could not confirm the reported event.Depuy synthes considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.

• Brand Name: GLOBAL SHD END FIN GLEN 40XS
• Common Device Name: GLOBAL ADVANTAGE IMPLANT : SHOULDER HUMERAL HEADS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 10214556
• Report Number: 1818910-2020-14751
• Device Sequence Number: 14094502
• Product Code: HSD
• UDI-Device Identifier: 10603295005063
• UDI-Public: 10603295005063
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K984541
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/10/2020

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?: No
• Operator of Device: Health Professional
• Device Model Number: 1128-40-000
• Device Catalogue Number: 113793025
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/10/2020
• Supplement Date Received by Manufacturer: 07/09/2020; 07/24/2020
• Initial Report FDA Received Date: 06/30/2020
• Supplement Report FDA Received Date: 07/13/2020; 07/27/2020
• 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 HUM HD 40X15.; GLOBAL ADVANTAGE STEM 10 MM.; GLOBAL SHD END FIN GLEN 40XS.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 67 YR
• Patient Weight: 106