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

Catalog Number	140760025
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Codes	Pain (1994); Discomfort (2330); Not Applicable (3189)
Date of Event	05/22/2018
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 that the patient had a delta reverse shoulder implanted approximately 2 years ago and recently began to experience pain and discomfort in her shoulder.Surgeon evaluated the patient and found out that the x-ray¿s indicated that the metaglene base plate was loose, a base plate screw was broken, and this patient would need a revision.Surgeon was asked why he thought the metaglene came loose and he suspected that due to the patient using her arm to walk with a cane and walker because patient recently had a knee replacement.During the revision surgery, surgeon said the components weren¿t really loose and that the base plate had migrated due to the poor bone quality.The glenoid was bone grafted and a new metaglene, 4 screws, glenosphere, and humeral cup were implanted.Doi: approximately 2 years ago; dor: (b)(6) 2018; right shoulder.
Additional Manufacturer Narrative
(b)(4).Investigation summary no device associated with this report was received for examination.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: METAGLENE LONG PEG +15MM
• Common Device Name: SHOULDER METAGLENE
• Manufacturer (Section D): DEPUY FRANCE SAS - 3003895575; 7 allee irene joliot-curie; b.p. 256; saint priest cedex 69801 ; FR 69801
• MDR Report Key: 7605439
• Report Number: 1818910-2018-62324
• Device Sequence Number: 10817425
• Product Code: HSD
• UDI-Device Identifier: 10603295423652
• UDI-Public: 10603295423652
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K120174
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/22/2018

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: 140760025
• Device Lot Number: 5209910
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/22/2018
• Supplement Date Received by Manufacturer: 07/17/2018
• Initial Report FDA Received Date: 06/15/2018
• Supplement Report FDA Received Date: 07/23/2018
• 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