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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMET ORTHOPEDICS UNKNOWN INSTRUMENT

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BIOMET ORTHOPEDICS UNKNOWN INSTRUMENT Back to Search Results
Model Number N/A
Device Problem Fracture (1260)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 05/19/2016
Event Type  Injury  
Manufacturer Narrative
(b)(4). The following report is submitted relay additional information the reported event was confirmed based on operative notes received. No product was received for evaluation. Operative notes for procedure performed on (b)(6) 2016 demonstrate that instrument fracture occurred intra-operatively. As stated by the surgeon there was no motion of the previously implanted integral femoral stem. The stem was noted to be well fixed, appropriately anteverted, and therefore left alone. The fractured tip fragment of the introducer/extraction device was embedded within the femoral implant. As stated by the surgeon, the fractured fragment was buried and would not cause any clinical issues. Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown. Compatibility check and complaint history review were not performed. A definitive root cause could not be determined with information provided. No corrective actions, preventive actions, or field actions resulted after investigation of this event. If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly. Zimmer biomet will continue to monitor for trends.
 
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.
 
Event Description
During a hip revision procedure, the inserter fractured. A piece was retained by the patient.
 
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Brand NameUNKNOWN INSTRUMENT
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
christina arnt
56 e. bell dr.
warsaw, IN 46582
5745273773
MDR Report Key6180948
MDR Text Key111265012
Report Number0001825034-2016-05237
Device Sequence Number1
Product Code HAW
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
PNI
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/28/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/16/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
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 Received09/28/2017
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 Unkown
Removal/Correction NumberN/A

Patient Treatment Data
Date Received: 12/16/2016 Patient Sequence Number: 1
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