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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US HUMERAL HEAD SIZE 46; SHOULDER HUMERAL HEADS
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DEPUY ORTHOPAEDICS INC US HUMERAL HEAD SIZE 46; SHOULDER HUMERAL HEADS Back to Search Results
Catalog Number 114020046
Medical Device Problem Code Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes Joint Dislocation (2374); No Code Available (3191)
Date of Event 08/30/2018
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
(b)(4).Investigation summary: no device associated with this report was received for examination.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.(b)(4).
 
Event or Problem Description
Posterior subluxations of the shoulder persisted, so that revision arthroplasty to a reverse shoulder implant with a glenoid bone graft was performed.
 
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Brand Name
HUMERAL HEAD SIZE 46
Common Device Name
SHOULDER HUMERAL HEADS
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
MDR Report Key8252411
Report Number1818910-2019-81053
Device Sequence Number2190308
Product Code KWS
UDI-Device Identifier10603295381242
UDI-Public10603295381242
Combination Product (Y/N)N
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2017
Device Explanted Year2018
Reporter Type Manufacturer
Report Source foreign,health professional,o
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 12/20/2018
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 Number114020046
Device Lot NumberHB0078
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 12/20/2018
Initial Report FDA Received Date01/16/2019
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
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