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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMET UK LTD. UNKNOWN SIZE 4 OXFORD BEARING; KNEE PROSTHESIS

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BIOMET UK LTD. UNKNOWN SIZE 4 OXFORD BEARING; KNEE PROSTHESIS Back to Search Results
Model Number N/A
Device Problem Fracture (1260)
Patient Problem Failure of Implant (1924)
Event Date 09/18/2014
Event Type  Injury  
Event Description
It was reported initial right unicompartmental knee replacement.Subsequently revised.During the revision noted wear to the bearing.The bearing was exchanged with the unknown component.The remaining unknown oxford components remained implanted.No contributing conditions, just worn and fractured implants attempts have been made and all additional information received has been included in this report.
 
Manufacturer Narrative
(b)(4).G2- australia.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.Part and lot number unknown.
 
Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional and/or corrected information.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of manufacturing records cannot be performed without product identification.Device is used for treatment.Medical records were provided and reviewed by a health care professional.Contributing factors of event osteoarthritis (oa), during the revision the bearing was found to be in 2 pieces.The bearing was exchanged with unknown component.With the available information, a definitive root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
 
Event Description
No further event information available at the time of this report. .
 
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Brand Name
UNKNOWN SIZE 4 OXFORD BEARING
Type of Device
KNEE PROSTHESIS
Manufacturer (Section D)
BIOMET UK LTD.
waterton industrial estates
bridgend CF31 3XA
UK  CF31 3XA
Manufacturer (Section G)
BIOMET UK LTD.
waterton industrial estates
bridgend CF31 3XA
UK   CF31 3XA
Manufacturer Contact
christina arnt
56 e. bell dr.
warsaw, IN 46582
5745273773
MDR Report Key16681293
MDR Text Key312682831
Report Number3002806535-2023-00096
Device Sequence Number1
Product Code NRA
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
N/A
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 05/17/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model NumberN/A
Device Catalogue NumberUNKNOWN
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 03/16/2023
Initial Date FDA Received04/05/2023
Supplement Dates Manufacturer Received04/27/2023
Supplement Dates FDA Received05/18/2023
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 Sequence Number1
Patient Outcome(s) Required Intervention; Hospitalization;
Patient SexMale
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