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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 UNK SHOULDER HUMERAL CUP DELTA XTEND
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DEPUY IRELAND - 9616671 UNK SHOULDER HUMERAL CUP DELTA XTEND Back to Search Results
Catalog Number UNK SHOULDER HUMERAL CUP DELTA
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Unspecified Infection (1930)
Event Date 11/08/2021
Event Type  Injury  
Manufacturer Narrative
Product complaint # (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
It was reported that the patient was revised from delta reverse shoulder implants due to infection.Part and lot numbers were unknown.Cement was not involved in any procedure.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 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.Device history lot : a manufacturing record evaluation (mre), was not possible because the required lot code was not provided.
 
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Brand Name
UNK SHOULDER HUMERAL CUP DELTA XTEND
Type of Device
SHOULDER HUMERAL CUP
Manufacturer (Section D)
DEPUY IRELAND - 9616671
loughbeg ringaskiddy co.
cork
EI 
Manufacturer (Section G)
DEPUY ORTHOPAEDICS INC 1818910
700 orthopaedic drive
warsaw IN 46581 0988
Manufacturer Contact
kara ditty-bovard
700 orthopaedic dr.
warsaw, IN 46581-0988
6107428552
MDR Report Key12916642
MDR Text Key281596619
Report Number1818910-2021-26945
Device Sequence Number1
Product Code HSD
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 11/17/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/02/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Catalogue NumberUNK SHOULDER HUMERAL CUP DELTA
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/03/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
UNK SHOULDER GLENOSPHERE DELTA XTEND; UNK SHOULDER HUMERAL CUP DELTA XTEND; UNK SHOULDER HUMERAL STEM DELTA XTEND; UNKNOWN SHOULDER GLENOSPHERE; UNKNOWN SHOULDER HUMERAL EPIPHYSIS DELTA XTEND; UNKNOWN SHOULDER HUMERAL EPIPHYSIS DELTA XTEND; UNKNOWN SHOULDER HUMERAL STEMS; UNKNOWN SHOULDER LOCKING SCREW; UNKNOWN SHOULDER LOCKING SCREW; UNKNOWN SHOULDER LOCKING SCREW; UNKNOWN SHOULDER LOCKING SCREW; UNKNOWN SHOULDER METAGLENE; UNKNOWN SHOULDER METAGLENE; UNKNOWN SHOULDER NON-LOCKING SCREW; UNKNOWN SHOULDER NON-LOCKING SCREW; UNKNOWN SHOULDER NON-LOCKING SCREW
Patient Outcome(s) Required Intervention;
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