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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 Fracture (1260); Insufficient Information (3190)
Patient Problems Osteopenia/ Osteoporosis (2651); No Information (3190)
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 acetabular plate lot #: unknown. Customer has indicated that the product will not be returned to zimmer biomet for investigation. The product remains implanted. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted.
 
Event Description
It was reported by the 411 group the patient underwent an initial tha at an unknown date. The patient has been indicated for a revision, however, a revision has not been reported. The sales rep was inquiring about implant identification. 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 Key10264218
MDR Text Key198873686
Report Number0001822565-2020-02541
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 distributor
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 08/10/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/13/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberN/A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received08/07/2020
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: 07/13/2020 Patient Sequence Number: 1
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