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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. MODULAR ARTHRODESIS ELLIPTICAL DIAPHYSEAL CONNECTOR; HSB
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ZIMMER BIOMET, INC. MODULAR ARTHRODESIS ELLIPTICAL DIAPHYSEAL CONNECTOR; HSB Back to Search Results
Model Number N/A
Device Problem Fracture (1260)
Patient Problems Failure of Implant (1924); Pain (1994); Metal Related Pathology (4530)
Event Date 01/10/2022
Event Type  Injury  
Event Description
It was reported that the patient's leg was amputated above the knee approximately five (5) years following knee arthroplasty after the patient's prosthesis fractured while getting out of bed and the patient fell.The patient was taken via ambulance after the fall and two (2) days later the surgeon amputated the leg.A portion of the rod was left in the leg to allow the patient to have a prosthesis at a later date.Attempts have been made, however, no additional information is available.
 
Manufacturer Narrative
(b)(4).Concomitant devices - modular arthrodesis nail 0 degree collar assembly catalog #: cp260600 lot #: 831610, modular arthrodesis nail elliptical diaphyseal connector 3cm catalog #: cp260608 lot #: 451850, orthopedic salvage system interlok cemented straight im tibial stem with screw 13mm x 150mm catalog #: 150446 lot #: 081830, modular arthrodesis nail elliptical diaphyseal connector 1cm catalog #: cp260606 lot #: 868080 the complainant has indicated that the product will not be returned to zimmer biomet for investigation, as a portion of the device was discarded and the other portion remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
 
Event Description
No further event information available at the time of this report.
 
Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b6, g3, g6, h2, h10.
 
Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: a1, b4, b5, b6, b7, d1, d2, d4, g3, g4, g6, h2, h6, h10.
 
Event Description
It was reported that the patient's leg was amputated above the knee approximately five (5) years following knee arthroplasty after the patient's prosthesis fractured while getting out of bed and the patient fell.The patient was taken via ambulance after the fall and two (2) days later the surgeon amputated the leg.A portion of the rod was left in the leg to allow the patient to have a prosthesis at a later date.Operative notes from the amputation noted metallosis was present in the joint without evidence of infection.Amputation was completed at the level end of the broken metallic rod.No intraoperative complications were reported and the patient was in stable condition in recovery.The patient was discharged six (6) days later.Attempts have been made, however, no additional information is available.
 
Event Description
No further event information available at the time of this report.
 
Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The device history records were reviewed and no discrepancies were identified.A definitive root cause could not be determined with the information provided.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
 
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Brand Name
MODULAR ARTHRODESIS ELLIPTICAL DIAPHYSEAL CONNECTOR
Type of Device
HSB
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
Manufacturer (Section G)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
Manufacturer Contact
christina arnt
56 e. bell dr.
warsaw, IN 46582
5745273773
MDR Report Key14110865
MDR Text Key289346779
Report Number0001825034-2022-00884
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K042409
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup,Followup,Followup
Report Date 08/18/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/14/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberN/A
Device Catalogue NumberCP260606
Device Lot Number868080
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received07/27/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/10/2015
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
Treatment
SEE H10 NARRATIVE
Patient Outcome(s) Hospitalization; Disability; Required Intervention;
Patient SexMale
Patient Weight84 KG
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