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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNK CUP; PROSTHESIS, HIP
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ZIMMER BIOMET, INC. UNK CUP; 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 10/28/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(4).Report source: foreign country: (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.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2019 - 05109.
 
Event Description
It was reported that the g7 e1 liner would not assemble with 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
Upon reassessment of the reported event, the cup was determined to be not reportable and did not contribute to the reported event.The initial report was forwarded in error and should be voided.
 
Manufacturer Narrative
Upon reassessment of the reported event, the cup was determined to be not reportable and did not contribute to the reported event.The initial report was forwarded in error and should be voided.
 
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Brand Name
UNK CUP
Type of Device
PROSTHESIS, HIP
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
MDR Report Key9314602
MDR Text Key195593411
Report Number0001825034-2019-05110
Device Sequence Number1
Product Code LPH
Combination Product (y/n)N
PMA/PMN Number
NI
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign,health pr
Type of Report Initial,Followup
Report Date 03/03/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/13/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberN/A
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received03/02/2020
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A
Patient Sequence Number1
Treatment
G7 NEUTRAL E1 LINER CAT#010000847, LOT#6569712.; UNK CUP.; UNK LINER.; UNK STEM.
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