MAUDE Adverse Event Report: BIOMET UK LTD. OXFORD PH3 CEMENTLESS FEM SZ M; PROSTHESIS, KNEE

Model Number N/A

Device Problems Migration or Expulsion of Device (1395); Scratched Material (3020)

Patient Problem No Information (3190)

Event Date 04/14/2016

Event Type  Injury  

Manufacturer Narrative

This user facility is outside of the united states.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.This product is manufactured by zimmer biomet (b)(4) and is not cleared or distributed in the u.S.However, this report is being submitted as zimmer biomet in (b)(4) manufactures a similar device in the united states under pma number p010014.Examination of returned device found no evidence of product non-conformance.During the evaluation, the femoral and tibial tray showed evidence of scratches on their articulating surfaces.However, a conclusive root cause of the event could not be determined.There are warnings in the package insert that state that this type of event can occur: under possible adverse effects, number 9 states, "loosening or migration of the implants can occur due to loss of fixation, trauma, malalignment, bone resorption, excessive activity." under warnings, number 3 states, "improper selection, placement, positioning, alignment and fixation of the implant components may result in unusual stress conditions which may lead to subsequent reduction in the service life of the prosthetic components." number 4 states, "in the event of excessive bone removal or inaccuracies in bone cuts leading to loose fit of cementless implants into the prepared bone, the oxford cemented implants should be used.In this case the cemented oxford instrument kits must be used and trial reduction must be conducted to ensure the natural knee kinematics are maintained." number 13 states, "the surgical technique should be followed.Deviations from the surgical technique could result in early loosening/failure of the device.Clinical outcome may be affected by component positioning.Proper placement of the implant should take into consideration individual patient anatomy as well as surgeon preference.The surgical technique sets forth guidelines for placement of the knee system." this report is number 2 of 2 mdr's filed for the same patient (reference 3002806535-2016-00223 and 00578).

Event Description

The patient was revised due to tibial subsidence.All components were removed and replaced.

• Brand Name: OXFORD PH3 CEMENTLESS FEM SZ M
• 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 CF31 -3XA ; UK CF31 3XA ; 0441656655
• MDR Report Key: 5817458
• MDR Text Key: 50288952
• Report Number: 3002806535-2016-00578
• Device Sequence Number: 1
• Product Code: NRA
• Combination Product (y/n): N
• Reporter Country Code: FI
• PMA/PMN Number: PN/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/22/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: N/A
• Device Catalogue Number: 154926
• Device Lot Number: 3613055
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/18/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/29/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/14/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention