MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 GLOBAL SHD END PEG GLEN 48; GLENOID (KEELED AND 5-PEGGED) IMPLANT : SHOULDER GLENOID

Catalog Number	113786025
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Unspecified Infection (1930); No Code Available (3191)
Date of Event	04/03/2019
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
Reason for revision: cuff failure rendering total anatomical replacement inappropriate for patient needs.9 months post implantation cuff failure resulted in total anatomic shoulder conversion to reverse shoulder prosthesis.Based on anatomic changes and not on failure of implanted prosthesis to function as intended.Glenoid peg shows signs of superior wear.All prosthesis successfully removed without complication.
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 code(s) 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.Corrective action was not indicated.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• 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. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 8554816
• Report Number: 1818910-2019-91699
• Device Sequence Number: 2207187
• Product Code: KWT
• UDI-Device Identifier: 10603295007265
• UDI-Public: 10603295007265
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K905786
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/03/2019

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: 113786025
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/03/2019
• Supplement Date Received by Manufacturer: 06/05/2019
• Initial Report FDA Received Date: 04/26/2019
• Supplement Report FDA Received Date: 06/06/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention