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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMET UK LTD. OXFORD PKS COCR SIZE D RM STD; PROSTHESIS, KNEE

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BIOMET UK LTD. OXFORD PKS COCR SIZE D RM STD; PROSTHESIS, KNEE Back to Search Results
Model Number N/A
Device Problem Migration or Expulsion of Device (1395)
Patient Problems Pain (1994); Swelling (2091)
Event Date 08/03/2016
Event Type  Injury  
Manufacturer Narrative
Current information is insufficient to permit a conclusion as to the cause of the event.Review of device history records show that lot released with no recorded anomaly or deviation.There are warnings in the package insert that state this type of event can occur: under possible adverse effects, number 10 states, "loosening or migration of the implants can occur due to loss of fixation, trauma, malalignment, bone resorption, excessive activity." number 20 states, "persistent pain." implant date - during 2014.
 
Event Description
Patient's right knee was revised approximately 2 years post-implantation due to pain, swelling, and loosening of the tibial component.
 
Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Complaint sample was evaluated and the reported event was not confirmed.The tibial tray shows evidence of burnishing on the fixation surface, which is indicative of the loosening of the tibial implant that was reported as the reason for revision.The presence of burnishing of the metal suggests that it was loose from the cement, as opposed to the cement being loose from the bone, although radiographs and the return of the cement mantle may help to confirm this.This may imply sub-optimal cementing of the tibial tray or that the tray was not clean and dry prior to the application of cement.It is also possible that the cement was left to cure for longer than optimal, resulting in reduced cohesion to the tray.The absence of radiographs or surgical reports prevents any assessment of implant position and selection.Information on the patient¿s height, weight and typical activity level have also not been made available.Therefore, the influence of such factors on the ultimate cause for revision cannot be determined.Dhr was reviewed and no discrepancies were found.Root cause was unable to 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.
 
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Brand Name
OXFORD PKS COCR SIZE D RM STD
Type of Device
PROSTHESIS, KNEE
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
daniel tilbury
waterton industrial estates
bridgend 
0441656655
MDR Report Key5900106
MDR Text Key52866972
Report Number3002806535-2016-00689
Device Sequence Number1
Product Code NRA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
PP010014
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 03/30/2017
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 Physician
Device Expiration Date03/31/2024
Device Model NumberN/A
Device Catalogue Number154725
Device Lot Number245420
Other Device ID NumberN/A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/26/2017
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 07/25/2016
Initial Date FDA Received08/24/2016
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received03/30/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/04/2014
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 Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age72 YR
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