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U.S. Department of Health and Human Services

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

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ZIMMER BIOMET, INC. UNKNOWN BONE SCREW PROSTHESIS, HIP Back to Search Results
Model Number N/A
Device Problem Fracture (1260)
Patient Problem No Information (3190)
Event Type  Injury  
Manufacturer Narrative
(b)(4). Implant date: (b)(6) 2018. Concomitant medical devices: item #: unknown, unknown bone screw, lot #: unknown; item #: unknown, unknown stem, lot #: unknown; 650-1057 cer bioloxd option hd 36mm 2904542; 650-1068 cer option type 1 tpr sleve +6 2922046; ep-105994 epoly 36mm rlc lnr mrom sz24 042820. Customer has indicated that the product will not be returned to zimmer biomet for investigation. The product location is unknown. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted. Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2020 - 03457.
 
Event Description
It was reported pmi group that a patient underwent right hip arthroplasty. The patient is considering revision surgery on an unknown date due to broken screws on current triflange. No additional information is available.
 
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Brand NameUNKNOWN BONE SCREW
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 Key10503098
MDR Text Key205993508
Report Number0001825034-2020-03458
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 company representative,distri
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup
Report Date 05/25/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/08/2020
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
Event Location No Information
Date Manufacturer Received05/25/2021
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 Invalid Data
Removal/Correction NumberN/A

Patient Treatment Data
Date Received: 09/08/2020 Patient Sequence Number: 1
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