MAUDE Adverse Event Report: BIOMET ORTHOPEDICS UK UNKNOWN; 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.A patient was identified in the article that underwent partial knee arthroplasty on an unknown date.Subsequently, patient underwent revision on an unknown date due to traumatic bearing dislocation and an associated acl injury 19 months after initial procedure.Screws there implanted and the bearing was removed and replaced.No further information has been provided.

Manufacturer Narrative

Initial reporter - the article was written by j.S weston-simons in the bone and joint journal (2014): 96-b:59-64.This information was originally reported on 1825034-2015-02228 which referenced a journal article written on a study that this patient took part in.

• Brand Name: UNKNOWN
• Type of Device: PROTHESIS, KNEE
• Manufacturer (Section D): BIOMET ORTHOPEDICS UK; waterton industrial estate; bridgend, south wales CF31 3XA; UK 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: 4799928
• MDR Text Key: 5930977
• Report Number: 0001825034-2015-02278
• Device Sequence Number: 1
• Product Code: NRA
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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
• Report Date: 04/29/2015

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: 04/29/2015
• 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
• Patient Age: 68 YR