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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMET ORTHOPEDICS RLC SCREWD PROV 10DEG 32MMSZ23; TEMPLATE

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BIOMET ORTHOPEDICS RLC SCREWD PROV 10DEG 32MMSZ23; TEMPLATE Back to Search Results
Model Number N/A
Device Problems Device Reprocessing Problem (1091); Device Contamination with Body Fluid (2317)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  Injury  
Manufacturer Narrative
The product identification necessary to review manufacturing history was not provided.Current information is insufficient to permit a conclusion as to the cause of the event.The following sections could not be completed with the limited information provided.Lot number - unknown.Manufacture date ¿ unknown.
 
Event Description
It was reported that patient underwent a total hip arthroplasty on an unknown date.During the procedure, it was noted the trial liner was not sufficiently cleaned prior to the procedure.Remnants of dried blood was noted while cleaning the trial liner.
 
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Brand Name
RLC SCREWD PROV 10DEG 32MMSZ23
Type of Device
TEMPLATE
Manufacturer (Section D)
BIOMET ORTHOPEDICS
56 e. bell drive
warsaw IN 46582
Manufacturer (Section G)
BIOMET ORTHOPEDICS
56 e. bell drive
warsaw IN 46582
Manufacturer Contact
megan haas
56 e. bell drive
warsaw, IN 46582
5743726700
MDR Report Key4016873
MDR Text Key22205186
Report Number0001825034-2014-07093
Device Sequence Number1
Product Code HWT
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
PEXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Physician
Type of Report Initial
Report Date 07/21/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/18/2014
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Physician
Device Model NumberN/A
Device Catalogue Number31-413733
Device Lot NumberUNKNOWN
Other Device ID NumberN/A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received07/21/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Removal/Correction NumberN/A
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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