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U.S. Department of Health and Human Services

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

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ZIMMER BIOMET, INC. UNKNOWN STEM PROSTHESIS, HIP Back to Search Results
Model Number N/A
Device Problems Corroded (1131); Material Erosion (1214); Unintended Movement (3026); Insufficient Information (3190)
Patient Problems Bone Fracture(s) (1870); Failure of Implant (1924); Pain (1994); Ambulation Difficulties (2544); No Information (3190); Metal Related Pathology (4530)
Event Date 05/07/2018
Event Type  Injury  
Manufacturer Narrative
(b)(4). Concomitant medical devices: item #: unknown, unknown head lot #: unknown; item #: unknown, unknown liner lot #: unknown; item #: unknown, unknown cup lot #: unknown. Customer has indicated that the product will not be returned to zimmer biomet for investigation. The product location is unknown. Multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2021 - 00267. Reported event was unable to be confirmed due to limited information received from the customer. Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown. Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided. If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly. Zimmer biomet will continue to monitor for trends.
 
Event Description
Patient's legal counsel reported patient underwent a right hip arthroplasty and was revised seven years later for unknown reasons. Attempts have been made and no further information has been provided.
 
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Brand NameUNKNOWN 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 Key11279485
MDR Text Key230288145
Report Number0001822565-2021-00268
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 Consumer,Health Professional,Distributor
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 02/03/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/04/2021
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 Received01/13/2022
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 Treatment Data
Date Received: 02/04/2021 Patient Sequence Number: 1
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