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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 UNK SHOULDER HUMERAL EPIPHYSIS DELTA XTEND
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DEPUY IRELAND - 9616671 UNK SHOULDER HUMERAL EPIPHYSIS DELTA XTEND Back to Search Results
Catalog Number UNK SHOULDER HUMERAL EPIPHYSIS
Device Problems Osseointegration Problem (3003); Migration (4003)
Patient Problem Inadequate Osseointegration (2646)
Event Date 04/07/2021
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 to address stem subsidence and loosening at the bone to implant interface.Doi: unknown dor: (b)(6) 2021 right shoulder.
 
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 device history record (dhr) review, was not possible because the required lot number was not provided.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Device history lot: the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).Where the lot code was provided, a manufacturing records evaluation (mre) was not performed.
 
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Brand Name
UNK SHOULDER HUMERAL EPIPHYSIS DELTA XTEND
Type of Device
SHOULDER HUMERAL EPIPHYSIS
Manufacturer (Section D)
DEPUY IRELAND - 9616671
loughbeg ringaskiddy co.
cork
EI 
MDR Report Key11713061
MDR Text Key248774260
Report Number1818910-2021-08534
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 04/07/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/23/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberUNK SHOULDER HUMERAL EPIPHYSIS
Was Device Available for Evaluation? No
Date Manufacturer Received05/21/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
DELTA XTEND MODULAR HUMERAL STEM SIZE 10; HUMERAL PE CUP 38/+3
Patient Outcome(s) Required Intervention;
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