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U.S. Department of Health and Human Services

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

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ZIMMER BIOMET, INC. UNK STEM PROSTHESIS, HIP Back to Search Results
Model Number N/A
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Unspecified Infection (1930)
Event Type  Injury  
Manufacturer Narrative
(b)(4). Foreign: country: (b)(6). Customer has indicated that the product will not be returned to zimmer biomet for investigation. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted. Miettinen, hannu ja. , miettinen, simo sa. , kettunen, jukka s. (2020) revision hip arthroplasty using a porous tantalum acetabular component. Hip international 00(0), 1-7. Https://doi. Org/10. 1177/1120700020913294. Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2021-00922, 0001822565-2021-00923.
 
Event Description
A journal article was retrieved from hip international (2020) that reported a retrospective study from finland (kuopio university hospital) that looked at the survivorship of tm revision hips. The purpose of the study was to investigate the 10-year survival of trabecular tantalum metal (tm) acetabulum component in revision hip arthroplasty operations and to evaluate complications leading to re-revision. The study reviewed 100 revision hip patients revised with a tm revision shell, unconstrained liner, 28mm head, and monoblock (35 hips) and revision components (65 hips) with additional screws in 45 hips and augmentation in 5 hips. The indication for revision was acetabular loosening (67), liner wear (19), loosening of both components (5), infection (2), protrusion (2), malposition (2), periprosthetic fracture (1), femoral loosening (1), and recurrent dislocation (1). The mean age of the patients at the time of revision was 69. 8 (sd 8. 0; range 48. 0¿91. 0) years. The mean follow-up time was 9. 4 years and the median was 11. 5 years (sd 4. 118; range 0. 1¿13. 4 years). The patients were routinely clinically followed with a 3-month postoperative visit and some patients were seen after that in extra follow-up evaluations from 1¿5 years after the revision surgery. It was reported in a journal article one patient died due to infection complications following revision surgery. Attempts have been made and no further information has been provided.
 
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Brand NameUNK 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 Key11602814
MDR Text Key243548533
Report Number0001822565-2021-00924
Device Sequence Number1
Product Code KWY
Combination Product (y/n)N
Reporter Country CodeFI
PMA/PMN Number
NI
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,l
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/20/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/01/2021
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? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received04/12/2021
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 Initial
Removal/Correction NumberN/A

Patient Treatment Data
Date Received: 04/01/2021 Patient Sequence Number: 1
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