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U.S. Department of Health and Human Services

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

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ZIMMER BIOMET, INC. UNKNOWN SHELL PROSTHESIS, HIP Back to Search Results
Model Number N/A
Device Problem No Apparent Adverse Event (3189)
Patient Problem No Information (3190)
Event Type  Injury  
Manufacturer Narrative
(b)(4). Concomitant medical products: unknown, unknown mallory head, unknown - unknown, unknown liner, unknown , unknown, unknown stem, unknown implanted in 1993. Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2018-04153, 0001822565-2018-04154, 0001822565-2018-04156 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.
 
Event Description
It was reported that the patient's hip is being revised on an unknown date due to unknown reasons. Attempts have been made and additional information on the reported event is unavailable.
 
Manufacturer Narrative
This follow-up report is being submitted to relay additional information. The following sections were updated: reported event was unable to be confirmed. X-ray review shows right total hip arthroplasty with cerclage wires over the distal femoral stem. No periprosthetic lucency. Hardware and wiring intact. Acetabular cup appears to demonstrate slight increased lateral inclination. Increased lateral inclination of the acetabular cup resulting in slight eccentric positioning of the femoral head. Device history record (dhr) review was unable to be performed as the item and lot number of the device involved in the event is unknown. Root cause could not 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 will be filed accordingly. Zimmer biomet will continue to monitor for trends. Other text : product not returned.
 
Event Description
No further event information available at the time of this report.
 
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Brand NameUNKNOWN SHELL
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 Key7767593
MDR Text Key116565305
Report Number0001822565-2018-04155
Device Sequence Number1
Product Code KWA
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 consumer,distributor
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 11/06/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/09/2018
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 Received10/18/2018
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: 08/09/2018 Patient Sequence Number: 1
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