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U.S. Department of Health and Human Services

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

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ZIMMER BIOMET, INC. UNKNOWN STEM PROSTHESIS, HIP Back to Search Results
Model Number N/A
Device Problem Fracture (1260)
Patient Problem Failure of Implant (1924)
Event Type  Injury  
Manufacturer Narrative
(b)(4). Journal article source: 1. Hemmila et al. , 2021: results section, page number 319 ¿ revision due to liner breakage was reported (https://doi. Org/10. 1080/17453674. 2021. 1879513) (b)(6) no product was returned or pictures provided; visual and dimensional evaluations could not be performed. Part and lot identification are necessary for review of device history records, neither were provided. Medical records were not provided. A definitive root cause cannot be determined. 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: 0001825034 - 2021-03451, 0001825034 - 2021-03452m, 0001825034-2021 03453.
 
Event Description
It was reported on 14-dec-2021, a journal article was retrieved from acta orthopaedica (2021) that reported a retrospective review of the finnish joint registry from finland that looked at the revision rates and survivorship of vitamin-e infused highly crosslinked polyethylene liners (vepe) compared to moderately crosslinked polyethylene liners. The study consisted of 2 groups with 2,723 hips in the vepe group and 2,707 hips in the reference group. The study group patients were operated on between january 1, 2008 and december 31, 2017, with a mean follow-up time of 5. 0 years (0¿9. 7). The reference group patients were operated on between january 1, 2000 and december 31, 2017, with a mean follow-up time of 11. 0 years (0¿18. 5). The study population had a mean age of 67 and 64 years respectively at time of surgery. It was reported in a journal article that 2 patients underwent a revision at an unknown date due to a unknown component fracture. Attempts have been made and additional information on the reported event is unavailable at this time.
 
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Brand NameUNKNOWN 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 Key13060669
MDR Text Key286660033
Report Number0001825034-2021-03450
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,Literature,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 12/22/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/22/2021
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 Received12/14/2021
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: 12/22/2021 Patient Sequence Number: 1
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