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U.S. Department of Health and Human Services

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

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ZIMMER BIOMET, INC. UNKNOWN VERSYS STEM PROSTHESIS, HIP Back to Search Results
Model Number N/A
Device Problems Appropriate Term/Code Not Available (3191); Noise, Audible (3273)
Patient Problems Pain (1994); Numbness (2415); Ambulation Difficulties (2544)
Event Date 08/15/2018
Event Type  Injury  
Manufacturer Narrative
This follow-up report is being submitted to relay additional information. Reported event was confirmed by review of operative notes and x-rays. Operative notes provided from a pre-revision office visit state that patient had been experiencing symptoms of pain, grinding, popping, instability and difficulty ambulating for approximately 8 months. Review of pre-revision x-rays show mild lateral asymmetric position of the prosthetic femoral head consistent with poly liner wear. There was slightly asymmetric lucency within the acetabulum and along gruen zones 1 and 7 of the femoral component. There was no evidence of component loosening. 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 will be filed accordingly. Zimmer biomet will continue to monitor for trends. Multiple mdr reports were filed for this event, please see associated reports: 0001822565 -2018 -05317, 0002648920 -2018 -00686, 0002648920 -2018 -00685.
 
Event Description
It was reported patient presented to physicians office approximately 22 years post implantation due to pain, grinding, popping/clicking, instability, numbness, and use of cane when walking. It was also noted that the left leg was longer than the right along with anterior and posterior impingement. Patient was scheduled for revision 2 months later where the head and liner components were removed and replaced. Attempts have been made and additional information on the reported event is unavailable at this time.
 
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Brand NameUNKNOWN VERSYS 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 Key7913815
MDR Text Key121853474
Report Number0001822565-2018-05318
Device Sequence Number1
Product Code KWY
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
PN/A
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,health profession
Reporter Occupation
Type of Report Initial
Report Date 09/26/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/27/2018
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?
Event Location No Information
Date Manufacturer Received09/17/2018
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

Patient Treatment Data
Date Received: 09/27/2018 Patient Sequence Number: 1
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