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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. RINGLOC BI-POLAR 28X44MM; PROSTHESIS, HIP
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ZIMMER BIOMET, INC. RINGLOC BI-POLAR 28X44MM; PROSTHESIS, HIP Back to Search Results
Catalog Number 11-165212
Device Problem Difficult to Insert (1316)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/15/2024
Event Type  malfunction  
Event Description
It was reported that during the procedure, after the implants were installed, the two cups would not remain engaged.There was no health impact or consequences to the patient.Attempts have been made and no further information is available.
 
Manufacturer Narrative
(b)(4).G2: taiwan; the device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch will be submitted.
 
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Brand Name
RINGLOC BI-POLAR 28X44MM
Type of Device
PROSTHESIS, HIP
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
p.o. box 587
warsaw IN 46581
Manufacturer (Section G)
ZIMMER BIOMET, INC.
56 e. bell drive
p.o. box 587
warsaw IN 46581
Manufacturer Contact
jennifer rapsavage
56 e. bell dr.
warsaw, IN 46582
5745260384
MDR Report Key18920926
MDR Text Key337861901
Report Number0001825034-2024-00683
Device Sequence Number1
Product Code JDI
UDI-Device Identifier00880304209640
UDI-Public(01)00880304209640(17)280616(10)66005121
Combination Product (y/n)N
Reporter Country CodeTW
PMA/PMN Number
K051569
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial
Report Date 03/11/2024
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 Catalogue Number11-165212
Device Lot Number66005121
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 02/19/2024
Initial Date FDA Received03/18/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/21/2023
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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