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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN TRAUMA SCREW ROD, FIXATION

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ZIMMER BIOMET, INC. UNKNOWN TRAUMA SCREW ROD, FIXATION Back to Search Results
Model Number N/A
Device Problem Device Dislodged or Dislocated (2923)
Patient Problem Joint Dislocation (2374)
Event Date 09/28/2016
Event Type  Injury  
Manufacturer Narrative
(b)(4). Upon reassessment of the reported event, it was determined to not be reportable as this device was not involved in the event. The initial report was submitted in error and should be voided.
 
Manufacturer Narrative
(b)(4). Concomitant products: unknown, unknown affixus nail, unknown. Report source, foreign ¿ events occurred in (b)(6). Report source, literature - cordero, j. Et al (2016). Surgical delay as a risk factor for wound infection after a hip fracture. International journal of the care of the injured, 47(3), 56-60. Doi: 10. 1016/s0020-1383(16)30607-6. Reported event was unable to be confirmed due to limited information received from the customer. Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown. Root cause was unable to be determined. 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. Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2017 - 08938.
 
Event Description
It was reported in a journal article that 2. 7% of patients experienced a dislocation of the prosthesis with unknown affixus trochanteric nails and unknown hiploc sliding-hip screw-plate. Attempts have been made and additional information on the reported event is unavailable.
 
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Brand NameUNKNOWN TRAUMA SCREW
Type of DeviceROD, FIXATION
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
Manufacturer (Section G)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
Manufacturer Contact
christina arnt
56 e. bell dr.
warsaw, IN 46582
5745273773
MDR Report Key6961524
MDR Text Key114574562
Report Number0001825034-2017-08939
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeSP
PMA/PMN Number
PN/A
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,literature
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/26/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/19/2017
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 Received10/25/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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

Patient Treatment Data
Date Received: 10/19/2017 Patient Sequence Number: 1
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