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

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.

• 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 Key: 5900106
• MDR Text Key: 52866972
• Report Number: 3002806535-2016-00689
• Device Sequence Number: 1
• Product Code: NRA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PP010014
• Number of Events Reported: 1
• 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

• Date FDA Received: 08/24/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 03/31/2024
• Device Model Number: N/A
• Device Catalogue Number: 154725
• Device Lot Number: 245420
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/26/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/07/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/04/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 72 YR