MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 GLOBAL FX STEM 8MM; GLOBAL FX IMPLANTS : SHOULDER HUMERAL STEMS

Catalog Number	112808000
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Pain (1994); Not Applicable (3189)
Date of Event	07/12/2018
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.
Event or Problem Description
Revision (l) hemi arthroplasty to reverse.Patient complaining of increasing pain over the past 3 years.Surgeon removed the global advantage hemi & replaced with djo reverse.Shoulder extraction instruments provided.Surgeon had some difficulty removing the humeral stem due to proximal cement.
Additional Manufacturer Narrative
Investigation summary: no device associated with this report was received for examination.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: product code 112808000, lot number y2hab1.Device history review: a dhr review was done for part number 112808000 batch number y2hab1 and no deviations or anomalies were found.If information is obtained that was not available for the initial medwatch , a follow-up medwatch, will be filed as appropriate.

• Brand Name: GLOBAL FX STEM 8MM
• Common Device Name: GLOBAL FX IMPLANTS : SHOULDER HUMERAL STEMS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910 ; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 7762332
• Report Number: 1818910-2018-66091
• Device Sequence Number: 1705716
• Product Code: HSD
• UDI-Device Identifier: 10603295004974
• UDI-Public: 10603295004974
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K984541
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/12/2018

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: 112808000
• Device Lot Number: Y2HAB1
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/12/2018
• Supplement Date Received by Manufacturer: 10/22/2018
• Initial Report FDA Received Date: 08/08/2018
• Supplement Report FDA Received Date: 10/24/2018
• 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: 72 YR