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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ENCORE MEDICAL L.P GLENOID, HEAD W/RETAINING SCREW, RSP, 36MM, NEUTRAL; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

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ENCORE MEDICAL L.P GLENOID, HEAD W/RETAINING SCREW, RSP, 36MM, NEUTRAL; SHOULDER PROSTHESIS, REVERSE CONFIGURATION Back to Search Results
Catalog Number 508-36-101
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Bone Fracture(s) (1870)
Event Date 10/18/2023
Event Type  Injury  
Manufacturer Narrative
Additional reporting on this event will be provided as a supplemental report to this document as soon as it becomes available.
 
Event Description
Revision surgery - due to fracture.
 
Manufacturer Narrative
Complaint has been evaluated and is similar to previous report number 1644408-2020-00011; 530-06-108, s801 - pain, revision surgery if additional information regarding the reported event is submitted at a future date, this investigation will be re-evaluated.
 
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Brand Name
GLENOID, HEAD W/RETAINING SCREW, RSP, 36MM, NEUTRAL
Type of Device
SHOULDER PROSTHESIS, REVERSE CONFIGURATION
Manufacturer (Section D)
ENCORE MEDICAL L.P
9800 metric blvd
austin TX 78758
Manufacturer (Section G)
ENCORE MEDICAL L.P
9800 metric blvd
austin TX 78758
Manufacturer Contact
james mcmahon
9800 metric blvd
austin, TX 78758
MDR Report Key18145742
MDR Text Key328224250
Report Number1644408-2023-01622
Device Sequence Number1
Product Code PHX
UDI-Device Identifier00888912024761
UDI-Public00888912024761
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K051075
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 12/01/2023
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
Device Operator Health Professional
Device Catalogue Number508-36-101
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 10/18/2023
Initial Date FDA Received11/15/2023
Supplement Dates Manufacturer Received12/01/2023
Supplement Dates FDA Received12/01/2023
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
509-00-036 LOT: UNKNOWN.
Patient Outcome(s) Required Intervention;
Patient Age76 YR
Patient SexMale
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