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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. EXPLOR 12X22MM IMPLANT HEAD; PROSTHESIS, ELBOW, HEMI-, RADIAL, POLYMER/EXTREMITIES

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ZIMMER BIOMET, INC. EXPLOR 12X22MM IMPLANT HEAD; PROSTHESIS, ELBOW, HEMI-, RADIAL, POLYMER/EXTREMITIES Back to Search Results
Catalog Number 11-210032
Device Problem Detachment of Device or Device Component (2907)
Patient Problem Failure of Implant (1924)
Event Date 12/03/2021
Event Type  Injury  
Manufacturer Narrative
(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2021-03421, 0001825034-2021-03423.Medical product: item#: unknown, unknown explore locking screw; lot#: unknown.Item#: unknown, unknown explore stem; item#: unknown.Customer has indicated that the product will not be returned to zimmer biomet for investigation, the product was requested but not returned by hospital.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
 
Event Description
It was reported that the patient underwent a left elbow arthroplasty approximately eight (8) years ago for an unknown reason.Subsequently, the patient was revised due to the loosening and disassociation of implants.
 
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.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Lot identification is necessary for review of device history records; lot identification was not provided.Part and lot identification are necessary for review of device history records, neither were provided.A definitive root cause cannot be determined.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
EXPLOR 12X22MM IMPLANT HEAD
Type of Device
PROSTHESIS, ELBOW, HEMI-, RADIAL, POLYMER/EXTREMITIES
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 Key13111182
MDR Text Key282915721
Report Number0001825034-2021-03422
Device Sequence Number1
Product Code KWI
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K040611
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 03/08/2022
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 Catalogue Number11-210032
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 12/02/2021
Initial Date FDA Received12/29/2021
Supplement Dates Manufacturer Received02/07/2022
Supplement Dates FDA Received03/08/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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; Required Intervention;
Patient Age48 YR
Patient SexFemale
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