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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN CUP; PROTHESIS, HIP

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ZIMMER BIOMET, INC. UNKNOWN CUP; PROTHESIS, HIP Back to Search Results
Model Number N/A
Device Problem Material Erosion (1214)
Patient Problems Cognitive Changes (2551); Metal Related Pathology (4530)
Event Type  Injury  
Manufacturer Narrative
(b)(4).D9: implant date 2011.D10: cat# unknown lot# unknown - unknown stem.Cat# unknown lot# unknown - unknown head.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2024-00135; 0001822565-2024-00136.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.
 
Event Description
It was reported that the patient underwent a hip arthroplasty approximately twelve years ago.Subsequently, the patient is being considered for a revision on an unknown date for cobalt in the bloodstream causing cognitive decline.Though requested, no additional information was available.
 
Event Description
No further event information is 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 evaluation could not be performed.Medical records were not provided.Part and lot identification are necessary for review of device history records and compatibility checks, and neither were provided.The reported issue cannot be confirmed; however, it was determined that the cup was likely unrelated to the reported issue.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
UNKNOWN CUP
Type of Device
PROTHESIS, HIP
Manufacturer (Section D)
ZIMMER BIOMET, INC.
1800 w. center st.
warsaw IN 46580
Manufacturer (Section G)
ZIMMER BIOMET, INC.
1800 w. center st.
warsaw IN 46580
Manufacturer Contact
jennifer rapsavage
56 e. bell dr.
warsaw, IN 46582
5745260384
MDR Report Key18487234
MDR Text Key332578937
Report Number0001822565-2024-00140
Device Sequence Number1
Product Code LZO
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 Consumer
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 01/16/2024
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
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 01/05/2024
Initial Date FDA Received01/10/2024
Supplement Dates Manufacturer Received01/16/2024
Supplement Dates FDA Received01/16/2024
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
Patient Outcome(s) Other;
Patient SexMale
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