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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 NEUTRAL E1 LINER 32MM F; PROSTHESIS, HIP
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ZIMMER BIOMET, INC. G7 NEUTRAL E1 LINER 32MM F; PROSTHESIS, HIP Back to Search Results
Model Number N/A
Device Problem Difficult to Insert (1316)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/20/2020
Event Type  malfunction  
Manufacturer Narrative
(b)(4).Report source: (b)(6).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.
 
Event Description
It was reported during surgery, the e1 liner would not assemble with the g7 acetabular shell.This surgery was finished with backup product.Attempts have been made and additional information on the reported event is unavailable at this time.
 
Event Description
No further event information available at the time of this report.
 
Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated/corrected updated: b4, b5, d4, d10, g4, h2, h3, h4, h6 reported event was confirmed by review of visual inspection of returned product; which was found to be heavily damaged on the rim, but otherwise in good overall condition.No notable damage was observed on the barb, outer radius, or scallops.The rim of the liner is imprinted with tool marks and scratches.Device history record (dhr) was reviewed and no discrepancies were found.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 - 2020 - 02264.
 
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Brand Name
G7 NEUTRAL E1 LINER 32MM F
Type of Device
PROSTHESIS, HIP
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
MDR Report Key9706546
MDR Text Key200284796
Report Number0001825034-2020-00620
Device Sequence Number1
Product Code LPH
Combination Product (y/n)N
PMA/PMN Number
K121874
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 06/08/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/13/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberN/A
Device Catalogue Number010000850
Device Lot Number6631203
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/11/2020
Was the Report Sent to FDA? No
Date Manufacturer Received06/05/2020
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A
Patient Sequence Number1
Treatment
BIOMET SHELL CAT#110010265 LOT#6627145; UNKNOWN HEAD; UNKNOWN STEM
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