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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMET TRAUMA HFN RH 125 DEG 11MM X 360MM ROD, FIXATION

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BIOMET TRAUMA HFN RH 125 DEG 11MM X 360MM ROD, FIXATION Back to Search Results
Model Number N/A
Device Problem Off-Label Use (1494)
Patient Problems Bone Fracture(s) (1870); Pain (1994); Discomfort (2330)
Event Date 12/28/2014
Event Type  Injury  
Manufacturer Narrative
This follow-up report is being submitted to relay additional information. Reported event was unable to be confirmed due to limited information received from the customer. Device history record (dhr) was reviewed and no discrepancies were found. Review of the complaint history determined that no further action(s) is/are required. Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided. 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
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
This follow-up report is being submitted to relay additional information. Reported event was confirmed by review of op notes. Device history record was reviewed and no discrepancies were found. The product identification is clearly specified on the product label. From the information available, the root cause for the reported issue is determined as user error. 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
Current information is insufficient to permit a conclusion as to the cause of the event.
 
Event Description
Legal counsel for patient reported that patient underwent a left hip fracture fixation procedure however, a right hip fracture nail was implanted. This has caused an alleged anterior cortical perforation of the distal femur. Physical therapy notes dated 61 days post-implantation state that the patient has continued pain and discomfort. No revision has been reported to date. This report is based on allegations set forth in plaintiff¿s complaint and the allegations contained therein are unverified.
 
Manufacturer Narrative
This follow-up report is being filed to relay additional information, which was unknown at the time of the initial medwatch. Concomitant medical product - ball nose guide wire 100cm, catalog#: 281001100, lot#: 678860; hfn lag screw 10. 5mm x 90mm, catalog#: 814510090, lot#: pp1212290f; 3. 2x444mm thrd guide pin ste, catalog#: 281001175, lot#: iv5ak5f; 3. 2x444mm thrd guide pin ste, catalog#: 281001175, lot#: jp7ap4f.
 
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Brand NameHFN RH 125 DEG 11MM X 360MM
Type of DeviceROD, FIXATION
Manufacturer (Section D)
BIOMET TRAUMA
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 Key6223537
MDR Text Key109129258
Report Number0001825034-2017-00048
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
PK100238
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation Attorney
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 06/04/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/04/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/30/2021
Device Model NumberN/A
Device Catalogue Number814311360
Device Lot NumberDMDCCG
Other Device ID NumberN/A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/31/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/06/2011
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage
Removal/Correction NumberN/A

Patient Treatment Data
Date Received: 01/04/2017 Patient Sequence Number: 1
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