MAUDE Adverse Event Report: JOHNSON & JOHNSON MEDICAL (SUZHOU) LTD. 3006356043 GLOBAL ADVANTAGE ECC HD 44X18; SHOULDER HEAD/GLENOSPHERE

Catalog Number	112844110
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 ECC HD 44X18
• Common Device Name: SHOULDER HEAD/GLENOSPHERE
• Manufacturer (Section D): JOHNSON & JOHNSON MEDICAL (SUZHOU) LTD. 3006356043; no.299 changyang st; suzhou industrial park; suzhou, jiangsu 21512 -6; CH 21512-6
• MDR Report Key: 7025375
• Report Number: 1818910-2017-28835
• Device Sequence Number: 13739290
• Product Code: HSD
• UDI-Device Identifier: 10603295005124
• UDI-Public: 10603295005124
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K992065
• 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: 112844110
• Device Lot Number: D16042671
• 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