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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN M/L TAPER STEM PROSTHESIS, HIP

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ZIMMER BIOMET, INC. UNKNOWN M/L TAPER STEM PROSTHESIS, HIP Back to Search Results
Model Number N/A
Device Problems Material Erosion (1214); Insufficient Information (3190)
Patient Problems Necrosis (1971); Metal Related Pathology (4530); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/25/2021
Event Type  Injury  
Manufacturer Narrative
(b)(4). Concomitant medical products: unknown-unknown versys head-unknown. Unknown- unknown m/l taper stem-unknown. Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2022-00854. Customer has indicated that the product will not be returned to zimmer biomet for investigation, product location unknown. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted. Device remains implanted.
 
Event Description
It was reported patient underwent a right hip revision approximately 6 years post implantation due to unknown reasons. The head was revised. Attempts have been made and additional information on the reported event is unavailable at this time.
 
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Brand NameUNKNOWN M/L TAPER STEM
Type of DevicePROSTHESIS, HIP
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 Key13927998
MDR Text Key288023778
Report Number0001822565-2022-00855
Device Sequence Number1
Product Code KWA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K192660
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/13/2022
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Date FDA Received03/28/2022
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? No
Date Manufacturer Received03/23/2022
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 NumberNI

Patient Treatment Data
Date Received: 03/28/2022 Patient Sequence Number: 1
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