MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 GLOBAL ADVANTAGE PC STEM 10MM; SHOULDER HUMERAL STEM/EPIPHYSIS

Catalog Number	113710050
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	No Information (3190)
Date of Event	08/17/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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
Der states that the implants were sitting too proud so removed and replaced.Per follow-up, implant allegedly oversized.
Additional Manufacturer Narrative
Additional narrative: no device associated with this report was received for examination.A worldwide complaint database search found no other reported incident(s) against the provided product/lot combination(s) since release for distribution depuy considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation will 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.

• Brand Name: GLOBAL ADVANTAGE PC STEM 10MM
• Common Device Name: SHOULDER HUMERAL STEM/EPIPHYSIS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910 ; 700 orthopaedic drive; warsaw IN 46582
• MDR Report Key: 7025425
• Report Number: 1818910-2017-28837
• Device Sequence Number: 2036599
• Product Code: MBF
• UDI-Device Identifier: 10603295007135
• UDI-Public: 10603295007135
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K011047
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 113710050
• Device Lot Number: C00564
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/17/2017
• Supplement Date Received by Manufacturer: 10/13/2017
• Initial Report FDA Received Date: 11/13/2017
• Supplement Report FDA Received Date: 11/14/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1