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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNKNOWN SHOULDER GLENOID
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DEPUY ORTHOPAEDICS INC US UNKNOWN SHOULDER GLENOID Back to Search Results
Catalog Number UNK SHOULDER GLENOID
Device Problem Loss of Osseointegration (2408)
Patient Problems Inadequate Osseointegration (2646); No Code Available (3191)
Event Date 07/31/2020
Event Type  Injury  
Manufacturer Narrative
(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
Event Description
The patient was revised due to natural progression of a cuff tear arthropathy.A revision from a total shoulder to a reverse shoulder was done.Received information reports loosening of glenoid.Doi: unknown, dor: (b)(6) 2020, unknown affected side.
 
Manufacturer Narrative
Product complaint (b)(4).Investigation summary: no device associated with this report was received for examination.A worldwide lot specific complaint database search, or manufacturing record evaluation, was not possible as the required lot number was not provided.The information received will be retained for trend analysis, post market surveillance, or other events within the quality system.
 
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Brand Name
UNKNOWN SHOULDER GLENOID
Type of Device
SHOULDER GLENOID
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
MDR Report Key10403121
MDR Text Key202769629
Report Number1818910-2020-18086
Device Sequence Number1
Product Code HSD
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 07/31/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/13/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberUNK SHOULDER GLENOID
Was Device Available for Evaluation? No
Date Manufacturer Received08/27/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
ANCHOR PEG GLENOID; GLOBAL ADVANTAGE HEAD; GLOBAL ADVANTAGE STEM
Patient Outcome(s) Required Intervention;
Patient Age57 YR
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