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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNK LINER; PROSTHESIS, HIP
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ZIMMER BIOMET, INC. UNK LINER; 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 12/04/2020
Event Type  malfunction  
Manufacturer Narrative
(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Report source: (b)(6).Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2021-00126.
 
Event Description
It was reported that the liner could not be inserted because the c-ring of the metal cup was deformed.Back up products were used.Attempts have been made and no further information has been provided.
 
Manufacturer Narrative
Upon receipt of additional information, it has been determined that this device is included in the product set reported under 0001825034-2021-00126.The initial report was submitted in error and should be voided.
 
Event Description
Upon receipt of additional information, it has been determined that this device is included in the product set reported under 0001825034-2021-00126.The initial report was submitted in error and should be voided.
 
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Brand Name
UNK LINER
Type of Device
PROSTHESIS, HIP
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
MDR Report Key11218918
MDR Text Key232001888
Report Number0001825034-2021-00164
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 company representative,foreig
Type of Report Initial,Followup
Report Date 01/25/2021
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
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 01/22/2021
Initial Date FDA Received01/22/2021
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A
Patient Sequence Number1
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