MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US GLOBAL SHD END PEG GLEN 48; GLENOID (KEELED AND 5-PEGGED) IMPLANT : SHOULDER GLENOID

Model Number	1137-86-025
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	11/24/2020
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
Patient underwent a partial revision right shoulder replacement.The glenoid component was removed and the neck taper and head was changed.
Additional 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 48
• 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
• MDR Report Key: 10985121
• Report Number: 1818910-2020-26744
• Device Sequence Number: 4258905
• Product Code: KWT
• UDI-Device Identifier: 10603295007265
• UDI-Public: 10603295007265
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2020
• 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): 11/24/2020

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: 1137-86-025
• Device Catalogue Number: 113786025
• Device Lot Number: D32JW1000
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/24/2020
• Supplement Date Received by Manufacturer: 02/16/2021
• Initial Report FDA Received Date: 12/10/2020
• Supplement Report FDA Received Date: 02/16/2021
• 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 AP 135 DEG TAPER ASSEM; GLOBAL AP HUMERAL HD 48X15 ECC; GLOBAL AP 135 DEG TAPER ASSEM; GLOBAL AP HUMERAL HD 48X15 ECC
• Outcome Attributed to Adverse Event: Required Intervention