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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ECHO POR FMRL RED NC 12X140MM; PROTHESIS, HIP

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ZIMMER BIOMET, INC. ECHO POR FMRL RED NC 12X140MM; PROTHESIS, HIP Back to Search Results
Model Number N/A
Device Problem Material Erosion (1214)
Patient Problems Pain (1994); Scar Tissue (2060); Synovitis (2094); Metal Related Pathology (4530); Unequal Limb Length (4534)
Event Date 09/25/2023
Event Type  Injury  
Event Description
It was reported that approximately 9 years post implantation of a right total hip arthroplasty, the patient was revised for concern of metallosis development, elevated metal ion levels, and pain.The patient was noted to have a 7mm discrepancy between limbs.During the revision of the femoral head and limb lengthening procedure, scar tissue and synovial inflammation were also noted.There were no reported complications.No additional information was available.
 
Manufacturer Narrative
(b)(4).D10: cat# us157856, lot# 086360, m2a-magnum pf cup 56odx50id.Cat# 157450, lot# 709400, m2a-magnum mod hd sz 50mm.Cat# 139259, lot# 105620, m2a magnum 42-50m tpr insrt +6.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.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2024-00860, 0001825034-2024-00861, and 0001825034-2024-00863.
 
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Brand Name
ECHO POR FMRL RED NC 12X140MM
Type of Device
PROTHESIS, 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 Key19011030
MDR Text Key339000428
Report Number0001825034-2024-00862
Device Sequence Number1
Product Code KWA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K070274
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer,Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial
Report Date 04/01/2024
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 Number192412
Device Lot Number536270
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 03/21/2024
Initial Date FDA Received04/01/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/01/2014
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberN/A
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
Patient SexFemale
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