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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMET UK LTD. OXF CEMENTLESS TIB GRV CUTTER
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BIOMET UK LTD. OXF CEMENTLESS TIB GRV CUTTER Back to Search Results
Model Number N/A
Device Problems Loose or Intermittent Connection (1371); Use of Device Problem (1670)
Patient Problems No Known Impact Or Consequence To Patient (2692); No Information (3190)
Event Date 05/03/2018
Event Type  Injury  
Manufacturer Narrative
(b)(4).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.(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 that whilst implanting an oxford cementless tibia what appeared to be a cementless keel groove cutter was used , but it looks more like a cemented keel groove cutter.Cementless keel groove cutter on set ref 32-422457.The instrument under investigation is reference 32-421510.Result was that the groove was too wide, implant was therefore loose and could be manually lifted out of the patient.The surgeon had to bail out to a cemented tibia.
 
Manufacturer Narrative
(b)(4).An oxford cementless groove cutter (item # 32-421510) has been returned to biomet uk ltd for evaluation.It is reported that item number 32-421510 was used during the implantation of an oxford partial knee procedure and that the instrument looked more like a cemented keel cutter.Investigation confirms that the item in question has not been issued by biomet since 2010.Current surgical technique confirms that tray number 32-423532 contains the cementless and cemented picks that should be used as part of the procedure.The item numbers of these picks are 32-422457 and 32-422936 respectively.Item number 32-421510 should not have been used in this procedure and is not identified or mentioned in the surgical technique.The manufacturing history record related to the involved product has been reviewed and does not show any non-conformity, rejection or concession that could be related to the reported event.All the lot (8 units) was accepted at the time of manufacturing.A review of the complaints data base for the past 3 years has found no similar reported events for this item.The reported item is not recognised as part of the current oxford kit and therefore should not have been used as part of the procedure.Investigation is completed based on current available information.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.
 
Event Description
It was reported that whilst implanting an oxford cementless tibia what appeared to be a cementless keel groove cutter was used , but it looks more like a cemented keel groove cutter.Cementless keel groove cutter on set ref 32-422457.The instrument under investigation is reference 32-421510.Result was that the groove was too wide, implant was therefore loose and could be manually lifted out of the patient.The surgeon had to bail out to a cemented tibia.
 
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Brand Name
OXF CEMENTLESS TIB GRV CUTTER
Manufacturer (Section D)
BIOMET UK LTD.
waterton industrial estates
bridgend CF31 3XA
UK  CF31 3XA
MDR Report Key7536350
MDR Text Key109497972
Report Number3002806535-2018-00857
Device Sequence Number1
Product Code HRY
Combination Product (y/n)N
PMA/PMN Number
PN/A
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other
Type of Report Initial,Followup
Report Date 01/22/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/23/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberN/A
Device Catalogue Number32-421510
Device Lot Number1169186
Other Device ID NumberN/A
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received01/17/2019
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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