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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN BIOMET BIOMETRIC FEMORAL STEM; PROSTHETIC, HIP

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ZIMMER BIOMET, INC. UNKNOWN BIOMET BIOMETRIC FEMORAL STEM; PROSTHETIC, HIP Back to Search Results
Model Number N/A
Device Problem Material Erosion (1214)
Patient Problems Pain (1994); Scar Tissue (2060); Metal Related Pathology (4530)
Event Date 04/28/2022
Event Type  Injury  
Manufacturer Narrative
(b)(4).D10: unknown biomet cup, unknown magnum head, unknown neck adapter.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2023-01997, 0001825034-2023-01991, 0001825034-2023-01996.The device will not be returned for analysis as it¿s location is not known; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch will be submitted.
 
Event Description
It was reported that the patient underwent a revision procedure 13 years and 8 months post implantation due to elevated metal ion levels.During the revision copious amount of black-stained tissue was encountered as well as a large amount of scar tissue.Revision was completed without complications.There is no additional 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; visual and dimensional evaluations could not be performed.Part and lot identification are necessary for review of device history records, neither were provided.Medical records/radiographs were provided and reviewed by a health care professional.A review of the available records identified findings of the reported issues.Black-stained tissue was found, large amounts of scar tissue was removed, cerclage cables were tightened proximally and distally.Complaint is confirmed.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.
 
Event Description
There is no update to the prior event description provided.
 
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Brand Name
UNKNOWN BIOMET BIOMETRIC FEMORAL STEM
Type of Device
PROSTHETIC, 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 Key17630293
MDR Text Key322022514
Report Number0001825034-2023-01995
Device Sequence Number1
Product Code KWA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
NI
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 09/15/2023
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 Lay User/Patient
Device Model NumberN/A
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 08/01/2023
Initial Date FDA Received08/28/2023
Supplement Dates Manufacturer Received09/13/2023
Supplement Dates FDA Received09/15/2023
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 Unknown
Removal/Correction NumberN/A
Patient Sequence Number1
Treatment
PLEASE SEE H10
Patient Outcome(s) Required Intervention; Hospitalization;
Patient SexMale
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