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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMET FRANCE S.A.R.L. VG ROCC TIB BRG UHMWPE 67.5X12; PROSTHESIS, KNEE

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BIOMET FRANCE S.A.R.L. VG ROCC TIB BRG UHMWPE 67.5X12; PROSTHESIS, KNEE Back to Search Results
Catalog Number P11V0612
Device Problem Delivered as Unsterile Product (1421)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/05/2023
Event Type  malfunction  
Manufacturer Narrative
(b)(4).G2-foreign- japan investigation of this incident is currently ongoing.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.
 
Event Description
It was reported that during a total knee arthroplasty, the nurse noticed a foreign substance (fibre) within the implant packaging.Surgery was completed with another implant.This event is related to a malfunction that could potentially lead to a sterility issue.Due diligence is in progress for this complaint; to date, whatever additional information received has been included in this report.
 
Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.Visual examination of the product and pictures has been done.Item and lot numbers outer and inner matches the complaint.Seal has been broken on inner tyvek.Hair like substance is seen in photos attached.No other damage noticed.A review of the device manufacturing records confirmed no abnormalities or deviations.Device is used for treatment.Reported event did occur in an operating room or as part of a medical procedure, but review of the medical records has not been performed, as the event is not related to the medical procedure.With the available information, a definitive root cause could not 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
VG ROCC TIB BRG UHMWPE 67.5X12
Type of Device
PROSTHESIS, KNEE
Manufacturer (Section D)
BIOMET FRANCE S.A.R.L.
plateau de lautagne bp75
valence cedex 26903
FR  26903
Manufacturer (Section G)
BIOMET FRANCE S.A.R.L.
plateau de lautagne bp75
valence cedex 26903
FR   26903
Manufacturer Contact
christina arnt
56 e. bell dr.
warsaw, IN 46582
5745273773
MDR Report Key18054279
MDR Text Key327191487
Report Number3006946279-2023-00089
Device Sequence Number1
Product Code NRA
UDI-Device Identifier03599870092811
UDI-Public(01)03599870092811(17)251012(10)0001512188
Combination Product (y/n)N
Reporter Country CodeJA
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 01/05/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberP11V0612
Device Lot Number0001512188
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 10/05/2023
Initial Date FDA Received11/02/2023
Supplement Dates Manufacturer Received12/12/2023
Supplement Dates FDA Received01/05/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/12/2020
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 SexPrefer Not To Disclose
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