MAUDE Adverse Event Report: BIOMET ORTHOPEDICS U.K. LTD. UNKNOWN KNEE; PROTHESIS, KNEE

Model Number N/A

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Damage to Ligament(s) (1952)

Event Type  Injury  

Event Description

Information was received based on review of a journal article titled, "the mid-term outcomes of the oxford domed lateral unicompartmental knee replacement" which aimed to assess the survival and clinical outcomes of the domed oxford unicompartimental knee replacement in a large patient cohort in the medium term using the oxford unicompartimental knee revision, manufactured at biomet.This study consisted of 265 consecutive knees in 258 patients that underwent partial knee arthroplasty between september 2004 and july 2012 due to isolated disease of the lateral compartment.A total of 13 knees had re-operations, of which four were for dislocation.All dislocations occurred in the first two years.Another, two re-operations were secondary to significant trauma that resulted in ruptured ligaments, and two were spontaneous.In 4 patients, the unicompartimental knee replacement was converted to a primary total knee replacement.At final follow-up, the implant survival at 8 years, with failure defined as any revision, was 92.1%.Specifically, for this designer study the dislocation rate was less then 1% at the eight year mark.In conclusion, the dome lateral oxford unicompartimental knee replacement using the oxford partial knee system manufactured at biomet, gives good clinical outcomes, low re-operation rates, revision rates, and dislocation rates in patients with isolated lateral compartmental disease.

Manufacturer Narrative

Current information is insufficient to permit conclusions as to the cause of the events.Event details and product identification was not provided for the patients mentioned in the journal article.The following sections could not be completed with the limited information provided.Date of event - unknown expiration date - unknown date implanted - unknown date explanted - unknown initial reporter - the article was written by j.S weston-simons in the bone and joint journal (2014): 96-b:59-64.Manufacture date ¿ unknown.

Manufacturer Narrative

This follow-up report is being filed to relay corrected event description.

Event Description

Information was received based on review of a journal article titled, "the mid-term outcomes of the oxford domed lateral unicompartmental knee replacement" which aimed to assess the survival and clinical outcomes of the domed oxford unicompartimental knee replacement in a large patient cohort in the medium term using the oxford unicompartimental knee revision, manufactured at biomet.This study consisted of 265 consecutive knees in 258 patients that underwent partial knee arthroplastys between september 2004 and july 2012 due to isolated disease of the lateral compartment.A total of 12 knees had re-operations, of which four were for dislocation.All dislocations occurred in the first two years.Another, two re-operations were secondary to significant trauma that resulted in ruptured ligaments, and two were spontaneous.In 4 patients, the unicompartimental knee replacement was converted to a primary total knee replacement.At final follow-up, the implant survival at 8 years, with failure defined as any revision, was 92.1%.Specifically, for this designer study the dislocation rate was less then 1% at the eight year mark.In conclusion, the dome lateral oxford unicompartimental knee replacement using the oxford partial knee system manufactured at biomet, gives good clinical outcomes, low re-operation rates, revision rates, and dislocation rates in patients with isolated lateral compartmental disease.

• Brand Name: UNKNOWN KNEE
• Type of Device: PROTHESIS, KNEE
• Manufacturer (Section D): BIOMET ORTHOPEDICS U.K. LTD.; waterton industrial estate; bridgend, south wales CF31 3XA
• Manufacturer (Section G): BIOMET ORTHOPEDICS; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: megan haas ; 56 e. bell drive; warsaw, IN 46582 ; 5743726700
• MDR Report Key: 4799923
• MDR Text Key: 16545330
• Report Number: 0001825034-2015-02228
• Device Sequence Number: 1
• Product Code: NRA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PUNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/06/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/27/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: N/A
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/06/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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