MAUDE Adverse Event Report: BIOMET ORTHOPEDICS UNKNOWN OXFORD PARTIAL KNEE

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problems Bone Fracture(s) (1870); No Known Impact Or Consequence To Patient (2692)

Event Type  Injury  

Event Description

Information was received based on review of a journal article titled, "medial femoral condyle fracture as an intraoperative complication of oxford unicompartmental knee replacement" which aimed to analyze the results and complications of treatment with an oxford unicompartmental knee replacement (oukr) by use of a case study.This case report describes a periprosthetic fracture of the medial femoral condyle as an intraoperative complication during oukr.A (b)(6) woman with symptomatic anteromedial osteoarthritis of the left knee, confirmed by stress radiographs, received an oukr by an experienced orthopaedic surgeon.The procedure was performed according to the oxford surgical technique guidelines using microplasty instrumentation and a 500-g hammer.During surgery, no remarkable findings were noticed.Directly after surgery, a minimally displaced coronal fracture of the medial condyle (i.E.A hoffa fracture) was seen on the lateral radiographs.The patient was treated conservatively with a non-weight-bearing long leg cast for 6 weeks with the knee in 10° of flexion without valgus or varus stress.In conclusion, oxford unicompartmental knee replacement (oukr) is associated with a low perioperative complication rate.While medial condyle fractures can occur during oukr, minimally displaced fractures of the medial femoral condyle after oukr can be treated conservatively with non-weight bearing mobilization for 6 weeks with the knee in extension, without residual functional impairment.

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 patient mentioned in the case study.It is likely that these complications have already been reported; however, it cannot be determined based on the limited information made available in the article.Should additional information relating to the events be received, the updated information will be forwarded to the fda.

• Brand Name: UNKNOWN OXFORD PARTIAL KNEE
• Type of Device: PARTIAL KNEE
• Manufacturer (Section D): BIOMET ORTHOPEDICS; 56 e. bell drive; warsaw IN 46582
• 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: 4458106
• MDR Text Key: 16306734
• Report Number: 0001825034-2015-00348
• Device Sequence Number: 1
• Product Code: NRA
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: PUNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/13/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/27/2015
• 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?: Yes
• Date Manufacturer Received: 01/13/2015
• 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): Required Intervention
• Patient Age: 63 YR