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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMET UK LTD. OXF FEM DRILL GDE LAT IM ADAPT; KNEE PROSTHESIS
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BIOMET UK LTD. OXF FEM DRILL GDE LAT IM ADAPT; KNEE PROSTHESIS Back to Search Results
Model Number N/A
Device Problems Component Missing (2306); Device Misassembled During Manufacturing /Shipping (2912); Manufacturing, Packaging or Shipping Problem (2975)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/20/2020
Event Type  malfunction  
Manufacturer Narrative
(b)(4).Initial report.Report source, foreign event occurred in (b)(6).Postal code: (b)(6).The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
 
Event Description
It was reported by the surgeon that the system was not user friendly and that the instrumentation was incomplete.The im adapter was missing.31-60 minutes delay of the surgical procedure reported.No harm of the patient or the user was reported.
 
Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated: a1, a2, b4, b5, d1, d2, d4, d10, g4, g7, h1, h2, h3, h5, h10.Additional information received: the shortage of the instruments in the set was noticed during a procedure.Product information received: device name: oxf fem drill gde lat im adapt, item: 32-423400, lot: unknown.Customer has indicated that the product will not be returned to zimmer biomet for investigation.No photographs available.The surgery was completed with other device: item: 32-423300.The investigation is in process.Once the investigation has been completed, a supplemental mdr will be submitted.Product has not been returned.
 
Event Description
It was reported by the surgeon, that the system was not user friendly and that the instrumentation was incomplete (lack of instruments).The im adapter was missing.The malfunction caused a 60 minute delay to surgery.No impact or consequences to the patient or the user was reported.
 
Manufacturer Narrative
(b)(4).This follow-up report is being submitted to make a correction.Section d1 & d2 corrected: product involved in the incident is an unknown oxford im instrument.No further information about the product has been provided until now.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
 
Event Description
It was reported by the surgeon that the system was not user friendly and that the instrumentation was incomplete.The oxford im adapter was missing.31-60 minutes delay of the surgical procedure reported.No harm of the patient or the user was reported.
 
Event Description
It was reported by the surgeon, that the system was not user friendly and that the instrumentation was incomplete (lack of instruments).The im adapter was missing.The malfunction caused a 60 minute delay to surgery.No impact or consequences to the patient or the user was reported.
 
Manufacturer Narrative
(b)(4).This follow-up report is being submitted to make a correction.The following sections were updated: b4, b5, g4, g7, h1, h2, h10.Upon reassessment of the reported event, it was determined an mir report should not have been submitted under the current manufacturer.This event will be reported by medwatch facility warsaw biomet - (b)(4).Therefore, biomet uk ltd.Will not be sending any follow-ups regarding this product.
 
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Brand Name
OXF FEM DRILL GDE LAT IM ADAPT
Type of Device
KNEE PROSTHESIS
Manufacturer (Section D)
BIOMET UK LTD.
waterton industrial estates
bridgend CF31 3XA
UK  CF31 3XA
MDR Report Key10851091
MDR Text Key242178516
Report Number3002806535-2020-00476
Device Sequence Number1
Product Code HXC
Combination Product (y/n)N
PMA/PMN Number
N/A
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup,Followup,Followup
Report Date 01/11/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/17/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberN/A
Device Catalogue Number32-423400
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received01/08/2020
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A
Patient Sequence Number1
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