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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. RINGLOC BI-POLAR 28X46MM; PROSTHESIS, HIP
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ZIMMER BIOMET, INC. RINGLOC BI-POLAR 28X46MM; PROSTHESIS, HIP Back to Search Results
Model Number N/A
Device Problems Positioning Failure (1158); Material Integrity Problem (2978)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/26/2020
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 -2021-00125.
 
Event Description
It was reported the liner could not be attached to the shell because the c-ring attached to the metal cup was deformed.Back up product was used.No adverse events have been reported as a result of the malfunction.Attempts have been made and additional information on the reported event is unavailable at this time.
 
Manufacturer Narrative
Upon reassessment of the reported event, this device was determined to be not reportable.No serious injury or harm to the patient reported for this event or prior events with same or similar products.The initial report was forwarded in error and should be voided.
 
Event Description
Upon reassessment of the reported event, this device was determined to be not reportable.No serious injury or harm to the patient reported for this event or prior events with same or similar products.The initial report was forwarded in error and should be voided.
 
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Brand Name
RINGLOC BI-POLAR 28X46MM
Type of Device
PROSTHESIS, HIP
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
MDR Report Key11208089
MDR Text Key227994626
Report Number0001825034-2021-00124
Device Sequence Number1
Product Code LPH
Combination Product (y/n)N
PMA/PMN Number
K051569
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 04/29/2021
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 Number11-165216
Device Lot Number782230
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 12/28/2020
Initial Date FDA Received01/21/2021
Supplement Dates Manufacturer Received04/29/2021
Supplement Dates FDA Received04/29/2021
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A
Patient Sequence Number1
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