MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 GLOBAL ANCHOR PEG GLENOID 44MM; GLENOID (STEPTECH AND ANCHOR PEG) : SHOULDER GLENOID

Catalog Number	113641025
Medical Device Problem Code	Loss of or Failure to Bond (1068)
Health Effect - Clinical Code	Not Applicable (3189)
Date of Event	08/07/2018
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.Concomitant medical products: global advantage stem 10 mm, 113710000; global advantage hum hd 44x18, 112844010.
Event or Problem Description
Revision global advantage, the surgeon; (b)(6).Primary implant date 2008.Global advantage in situ, glenoid component loose - as per surgeon.Stem well fixed - as per surgeon.Loose due to length of time in situ - as per surgeon.Patient had a previous shoulder injury in 1993.Glenoid removed in one piece.Multiple specimens taken, images uploaded to unity.Patient (b)(6).
Additional Manufacturer Narrative
(b)(4).Investigation summary no device associated with this report was received for examination.Photographs were included for review.Depuy synthes considers the investigation closed.If information is obtained that was not available for the initial medwatch , a follow-up medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: GLOBAL ANCHOR PEG GLENOID 44MM
• Common Device Name: GLENOID (STEPTECH AND ANCHOR PEG) : SHOULDER GLENOID
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 7832810
• Report Number: 1818910-2018-68155
• Device Sequence Number: 1263598
• Product Code: KWS
• UDI-Device Identifier: 10603295006961
• UDI-Public: 10603295006961
• Combination Product (Y/N): N
• PMA/510(K) Number: K981487
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/07/2018

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 Catalogue Number: 113641025
• Device Lot Number: B77HP1
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/07/2018
• Supplement Date Received by Manufacturer: 10/25/2018
• Initial Report FDA Received Date: 08/30/2018
• Supplement Report FDA Received Date: 11/02/2018
• 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
• Patient Age: 55 YR