MAUDE Adverse Event Report: DEPUY FRANCE SAS 3003895575 US METAGLENE LONG PEG +15 MM; SHOULDER METAGLENE

Catalog Number	140760025
Medical Device Problem Code	Loss of Osseointegration (2408)
Health Effect - Clinical Code	Pain (1994)
Date of Event	08/04/2017
Type of Reportable Event	Serious Injury
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 patient had right reverse tsa last year and went to doctor because he said he moved his shoulder and heard a "pop" and felt pain.Surgeon took x-rays and saw a broken screw and metaglene had come loose at the bone to implant interface.
Additional Manufacturer 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.A worldwide lot specific complaint database search, or device history record (dhr) review was not possible for the unknown lot code(s).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: US METAGLENE LONG PEG +15 MM
• Common Device Name: SHOULDER METAGLENE
• Manufacturer (Section D): DEPUY FRANCE SAS 3003895575; 7 allée irène joliot curie; bp 256; saint priest cedex, rhone alpes 69801 ; FR 69801
• MDR Report Key: 6838244
• Report Number: 1818910-2017-24004
• Device Sequence Number: 65470
• Product Code: HSD
• UDI-Device Identifier: 10603295423652
• UDI-Public: 10603295423652
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K120174
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• 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): 08/04/2017

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: 140760025
• Device Lot Number: 5205366
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/04/2017
• Supplement Date Received by Manufacturer: 09/06/2017
• Initial Report FDA Received Date: 09/01/2017
• Supplement Report FDA Received Date: 09/07/2017
• 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: 62 YR