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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ENCORE MEDICAL, L.P. DISCOVERY ELBOW DISC HUM 3.5X84MM RT FLANGE C

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ENCORE MEDICAL, L.P. DISCOVERY ELBOW DISC HUM 3.5X84MM RT FLANGE C Back to Search Results
Catalog Number 114903
Device Problem Loose or Intermittent Connection (1371)
Patient Problem No Code Available (3191)
Event Date 06/27/2016
Event Type  Injury  
Event Description
Revision surgery - due to excessive osteolysis, the patient was having looseness.
 
Manufacturer Narrative
Manufacturer narrative: the reason for this revision surgery was excessive osteolysis. The in-vivo length of service for the patient's implant was 7. 2 months. The healthcare professional indicated there was no delay in surgery and another suitable device was available for use. The revision surgery was completed as intended. The device was disposed of at the hospital and not made available to djo surgical for examination. A review of the device history records (dhrs) revealed no discrepancies or issues with the manufacturing history of this part. All critical dimensions and specifications in effect at the time the part was manufactured were met. The product complaint report history was reviewed and no trends or on-going issues were deemed as present or in need of review. The root cause of this event was a report of patient joint looseness due to osteolysis. The scope of this investigation is limited without having the parts available to djo surgical for evaluation. Other conditions relating to this event could not be determined with confidence. Inventory containment is not required since there are no indications of a product or process issue affecting implant safety or effectiveness.
 
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Brand NameDISCOVERY ELBOW
Type of DeviceDISC HUM 3.5X84MM RT FLANGE C
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
teffany hutto
9800 metric blvd.
austin, TX 78758-5445
5128346255
MDR Report Key5808859
MDR Text Key49989269
Report Number1644408-2016-00484
Device Sequence Number1
Product Code JDC
UDI-Device Identifier00888912225113
UDI-Public(01)00888912225113
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K090473
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 05/26/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/20/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number114903
Device Lot Number962430
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received08/12/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/29/2014
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 07/20/2016 Patient Sequence Number: 1
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