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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMET ORTHOPEDICS MODULAR SPLINED STEM 40MM PROSTHESIS, KNEE

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BIOMET ORTHOPEDICS MODULAR SPLINED STEM 40MM PROSTHESIS, KNEE Back to Search Results
Model Number N/A
Device Problem Fitting Problem (2183)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/28/2015
Event Type  Malfunction  
Manufacturer Narrative

Examination of device found evidence of product non-conformance. The parts returned contained an undersized taper found to be nonconforming. Most likely evidence of a manufacturing process deficiency. It was determined to be an isolated incident.

 
Event Description

It was reported a patient underwent an initial knee arthoplasty procedure on (b)(6) 2015. During the procedure, it was reported that position of the stem pin and tray hole did not match causing the tray and the stem to not fit well. There was a gap between the stem and the plate so the press fit was shallower than usual. The surgeon thought the pin might be pressed obliquely so he tried to disconnected the stem and the tray but could not. He felt that they were well fixed and he decided to neatly tighten post screw to complete the procedure. No adverse event occurred.

 
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Brand NameMODULAR SPLINED STEM 40MM
Type of DevicePROSTHESIS, KNEE
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 Key5322741
MDR Text Key34922704
Report Number0001825034-2015-05105
Device Sequence Number1
Product Code MBH
Combination Product (Y/N)N
PMA/PMN NumberPK080361
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type FOREIGN,USER FACILITY
Reporter Occupation
Type of Report Initial
Report Date 12/18/2015
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received12/23/2015
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator
Device MODEL NumberN/A
Device Catalogue Number141369
Device LOT Number419570
OTHER Device ID NumberN/A
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/18/2015
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured07/23/2015
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberN/A

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