MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US GLOBAL ANCHOR PEG GLENOID 56MM; GLENOID (STEPTECH AND ANCHOR PEG) : SHOULDER GLENOID

Catalog Number	113644025
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Pain (1994); Osteolysis (2377); No Code Available (3191)
Date of Event	09/11/2019
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
Primary surgery: (b)(6) 2006.Revision surgery was carried out due to glenoid component loosening and pain.The surgeon removed the humeral head and the loose glenoid component and replaced with new implants.Osteolysis medial to the glenoid component was noted, specimens harvested for culture.The surgeon did indicate that the patient is currently being treated for cancer and that the osteolytic reaction medial to the glenoid component may be as a result of this treatment or the disease.No ae reported, no delay in the surgery.Relevant patient pre-existing conditions: treated for lung cancer.
Additional Manufacturer Narrative
(b)(4).No device was received.Root cause undetermined.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Additional Manufacturer Narrative
Product complaint (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Correction: h6(device code).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: GLOBAL ANCHOR PEG GLENOID 56MM
• Common Device Name: GLENOID (STEPTECH AND ANCHOR PEG) : SHOULDER GLENOID
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 9146964
• Report Number: 1818910-2019-107330
• Device Sequence Number: 3107405
• Product Code: HSD
• UDI-Device Identifier: 10603295007029
• UDI-Public: 10603295007029
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2006
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/01/2019

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: 113644025
• Device Lot Number: AK6G71000
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/11/2019
• Supplement Date Received by Manufacturer: 09/29/2019; 11/28/2019
• Initial Report FDA Received Date: 10/02/2019
• Supplement Report FDA Received Date: 10/29/2019; 12/03/2019
• 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
• Patient Age: 81 YR