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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ECHO B-MTRC MP FP SO 13; PROSTHESIS, HIP

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ZIMMER BIOMET, INC. ECHO B-MTRC MP FP SO 13; PROSTHESIS, HIP Back to Search Results
Model Number N/A
Device Problems Loss of or Failure to Bond (1068); Unstable (1667)
Patient Problems Fall (1848); Bone Fracture(s) (1870)
Event Date 09/29/2019
Event Type  Injury  
Manufacturer Narrative
(b)(4).Concomitant medical products: 010000663 ¿ g7 shell ¿ 6549351, 010000857 ¿ g7 liner ¿ 6487188, 12115121 ¿ femoral head ¿ 2971324.Customer has indicated that the product will not be returned to zimmer biomet as the product location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
 
Event Description
It was reported that a patient underwent a right hip revision following a ground level fall and sustaining a periprosthetic fracture.During the procedure, the shell was left intact and the head, liner and stem components were removed and replaced without complications.Attempts have been made and additional information on the reported event is unavailable at this time.
 
Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Reported event was confirmed by review of medical records noting patient experienced a ground level fall and a periprosthetic fracture leading to an unstable and loose hip prosthesis.The fracture was reduced and stabilized with a mini frag plate and cerclage cables.Dhr was reviewed and no discrepancies were found.The root cause is 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.
 
Event Description
No additional event information to report at this time.
 
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Brand Name
ECHO B-MTRC MP FP SO 13
Type of Device
PROSTHESIS, HIP
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
MDR Report Key9494579
MDR Text Key173457550
Report Number0001825034-2019-05624
Device Sequence Number1
Product Code LPH
UDI-Device Identifier00880304697805
UDI-Public00880304697805
Combination Product (y/n)N
PMA/PMN Number
K143009
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,study
Type of Report Initial,Followup
Report Date 04/07/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model NumberN/A
Device Catalogue Number193013
Device Lot Number744050
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 11/26/2019
Initial Date FDA Received12/19/2019
Supplement Dates Manufacturer Received03/31/2020
Supplement Dates FDA Received04/08/2020
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Weight121
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