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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. BI-METRIC HAP 12X140; PROSTHESIS, HIP
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ZIMMER BIOMET, INC. BI-METRIC HAP 12X140; PROSTHESIS, HIP Back to Search Results
Model Number N/A
Device Problem Material Erosion (1214)
Patient Problem No Code Available (3191)
Event Date 11/12/2019
Event Type  Injury  
Manufacturer Narrative
(b)(4).Concomitant medical products: catalog number: 15-105054, lot number:356000, brand name: m2a 38 cup unknown ceramic head.Report source: foreign: (b)(6).Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2020-01994.Customer has indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Device remains implanted in the patient.
 
Event Description
It was reported that the patient experienced elevated metal ions approximately 10 years post implantation.Patient has been added to a waiting list for revision surgery, however, no revision has been reported to date.Additional information on the reported event is unavailable at this time.
 
Event Description
Upon receipt of additional information it has been determined that the reported device did not cause or contribute to the event.Event is no longer considered reportable, and initial report should be voided.
 
Manufacturer Narrative
Upon receipt of additional information it has been determined that the reported device did not cause or contribute to the event.Event is no longer considered reportable, and initial report should be voided.
 
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Brand Name
BI-METRIC HAP 12X140
Type of Device
PROSTHESIS, HIP
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
MDR Report Key10066488
MDR Text Key192134055
Report Number0001825034-2020-01993
Device Sequence Number1
Product Code KWY
Combination Product (y/n)N
PMA/PMN Number
N/A
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 09/01/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/18/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberN/A
Device Catalogue Number162032
Device Lot Number1673488
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received08/25/2020
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age74 YR
Patient Weight70
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