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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ECHO POR FMRL RED NC 9X125MM; PROSTHESIS, HIP

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ZIMMER BIOMET, INC. ECHO POR FMRL RED NC 9X125MM; PROSTHESIS, HIP Back to Search Results
Model Number N/A
Device Problem Positioning Failure (1158)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/03/2020
Event Type  malfunction  
Manufacturer Narrative
(b)(4).Product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2020 - 03326, 0001825034 - 2020 - 03327, 0001825034 - 2020 - 03328.
 
Event Description
It was reported that the surgeon reamed and broached to the appropriate size for the implant being implanted.The surgeon indicated the implants did not fit the same way the broach fit.Each of the implants included in this were immediately explanted until the desired fit of the final implant was achieved.Attempts have been made and no further information has been provided.
 
Event Description
No further event information available at the time of this report.
 
Manufacturer Narrative
Cmp-0620794 this follow-up report is being submitted to relay additional information.Updated: b4, b5, g4, h2, h3, h6 complaint sample was evaluated and the reported event was not confirmed.Device history record (dhr) was reviewed and no discrepancies relevant to the reported event were found.Device analysis indicated that the device met specification.Device was returned and evaluated against the complaint.Visual inspection found the stem to be in good overall condition with no major damage.Scratching was observed on the neck flats and polished distal tip of the stem.Dimensional analysis was performed to identify the stem.Both the overall length and porous thickness at cross section a-a were found to be within specification for a 9mm echo stem.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
 
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Brand Name
ECHO POR FMRL RED NC 9X125MM
Type of Device
PROSTHESIS, HIP
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
MDR Report Key10443402
MDR Text Key204056974
Report Number0001825034-2020-03325
Device Sequence Number1
Product Code KWA
UDI-Device Identifier00887868260704
UDI-Public00887868260704
Combination Product (y/n)N
PMA/PMN Number
K070274
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,health profession
Type of Report Initial,Followup
Report Date 08/27/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberN/A
Device Catalogue Number192409
Device Lot Number539500
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/06/2020
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 08/06/2020
Initial Date FDA Received08/24/2020
Supplement Dates Manufacturer Received08/27/2020
Supplement Dates FDA Received08/28/2020
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A
Patient Sequence Number1
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