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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN HEAD HIP PROSTHESIS

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ZIMMER BIOMET, INC. UNKNOWN HEAD HIP PROSTHESIS Back to Search Results
Model Number N/A
Device Problems Corroded (1131); Material Erosion (1214)
Patient Problems Pain (1994); Reaction (2414)
Event Type  Injury  
Manufacturer Narrative
(b)(4). Customer has indicated that the product will not be returned to zimmer biomet for investigation, due to unknown product location. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted. Concomitant medical products: item # unknown, unknown stem lot # unknown. Item # unknown, unknown cup lot # unknown. Item # unknown, unknown liner lot # unknown.
 
Event Description
It was reported that a surgeon has requested a custom implant for a patient that is scheduled to be receiving a hip revision on an unknown date approximately 9 years post op due to pain, metallosis, elevated metal ions, and corrosion.
 
Manufacturer Narrative
Upon receipt of additional information, it was determined this product should not have been reported under this mfr number. This report should be voided and a corrected report will be filed under mfr number (b)(4).
 
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Brand NameUNKNOWN HEAD
Type of DeviceHIP PROSTHESIS
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 Key7458536
MDR Text Key106437812
Report Number0001822565-2018-02280
Device Sequence Number1
Product Code KWY
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
PNI
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/06/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/25/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/29/2018
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 Treatment Data
Date Received: 04/25/2018 Patient Sequence Number: 1
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