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U.S. Department of Health and Human Services

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

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ZIMMER BIOMET, INC. UNK VERSYS STEM PROSTHESIS, HIP Back to Search Results
Model Number N/A
Device Problems Loosening of Implant Not Related to Bone-Ingrowth (4002); Migration (4003)
Patient Problem Failure of Implant (1924)
Event Date 05/09/2022
Event Type  Injury  
Manufacturer Narrative
(b)(4). Component code: mechanical (g04) - stem. Reported event was confirmed due to the review of medical records. Radiographs were provided and reviewed by a health care professional. Review of the available records identified the following: eccentric positioning of the femoral stem with respect to the femur. Acetabular cup opponent appears normal. No periprosthetic lucencies. Bones appear well mineralized. 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 - 2022 - 01675.
 
Event Description
It was reported the patient underwent a right hip revision approximately 22 years post implantation due to stem & cup loosening and migration. No additional information.
 
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Brand NameUNK VERSYS STEM
Type of DevicePROSTHESIS, HIP
Manufacturer (Section D)
ZIMMER BIOMET, INC.
1800 w. center st.
warsaw IN 46580
Manufacturer (Section G)
ZIMMER BIOMET, INC.
1800 w. center st.
warsaw IN 46580
Manufacturer Contact
jennifer rapsavage
56 e. bell dr.
warsaw, IN 46582
5745260384
MDR Report Key14574550
MDR Text Key293189826
Report Number0001822565-2022-01674
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 Health Professional,Distributor
Reporter Occupation
Type of Report Initial
Report Date 06/02/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/02/2022
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 Received05/13/2022
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: 06/02/2022 Patient Sequence Number: 1
Treatment
UNK CUP; UNK HEAD; UNK LINER
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