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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TAPERLOC POR FMRL 15X150; PROSTHESIS, HIP
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ZIMMER BIOMET, INC. TAPERLOC POR FMRL 15X150; PROSTHESIS, HIP Back to Search Results
Model Number N/A
Device Problem Separation Failure (2547)
Patient Problems Hematoma (1884); Unspecified Infection (1930); Swelling (2091)
Event Date 12/28/2014
Event Type  Injury  
Manufacturer Narrative
(b)(4).Concomitant medical products: m2a-magnum mod hd sz 52mm, pn 157452, ln 101240.M2a-magnum 52-60mm tpr insrt-3, pn 139266, ln 068770.M2a-magnum pf cup 58odx52id, pn us157858, ln 722540.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2020-00101-1, 0001825034-2020-00102-1, 0001825034-2020-00103-1.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.
 
Event Description
Primary right tha performed.Patient subsequently developed elevated metal ions and noise.Attempted revision procedure occurred 9 years later, and unable to disengage femoral head, surgical procedure was aborted and surgical site was irrigated and closed.Approximately 1 week post aborted procedure, patient developed fever and superficial surgical site infection.I&d of surgical site performed 9 days later, no components removed.Patient received iv antibiotic treatment.
 
Manufacturer Narrative
Upon receipt of additional information, it was determined this product should not have been reported under this report number.This report should be voided and a corrected report will be filed under report number 0001825034-2020-00106.
 
Event Description
Upon receipt of additional information, it was determined this product should not have been reported under this report number.This report should be voided and a corrected report will be filed under report number 0001825034-2020-00106.
 
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Brand Name
TAPERLOC POR FMRL 15X150
Type of Device
PROSTHESIS, HIP
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
MDR Report Key9706659
MDR Text Key179270081
Report Number0001825034-2020-00650
Device Sequence Number1
Product Code LPH
Combination Product (y/n)N
PMA/PMN Number
K030055
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 05/18/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberN/A
Device Catalogue Number103208
Device Lot Number301550
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 01/22/2020
Initial Date FDA Received02/13/2020
Supplement Dates Manufacturer Received05/18/2020
Supplement Dates FDA Received05/18/2020
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Weight113
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