MAUDE Adverse Event Report: BIOMET ORTHOPEDICS UNKNOWN KNEE; PROSTHESIS, KNEE

Model Number N/A

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Pulmonary Embolism (1498); Angina (1710); Unspecified Infection (1930); Pain (1994); Staphylococcus Aureus (2058); Swelling (2091); Partial thickness (Second Degree) Burn (2694)

Event Type  Injury  

Event Description

J bone joint surg [br] 2006; 88-b: 54-60 doi: 10.1302/0301-620x.88b1.17114 pandit, h., et al information was received based on review of a journal article titled, "the oxford medial unicompartmental knee replacement using a minimally-invasive approach" which aimed to determine the complication rate, the clinical outcome and the midterm survival following the procedure using the oxford implant, manufactured at biomet.The study was conducted over a period of seven (7) years (june 1998 to july 2005) and involved six-hundred eighty-eight (688) knees.The journal article reports the following revisions by reason: four (4) revisions due to infection, three (3) revisions due to dislocation, two (2) revisions due to unexplained pain.The journal article reports the following interventions by reason: four (4) manipulations under anaesthesia to improve flexion, two (2) arthroscopies for persistent pain and/or swelling, one (1) debridement for partial thickness chondral lesion, one (1) debridement for mrsa infection.The journal article reports the following procedural related complications: three (3) pulmonary emboli, one (1) severe angina.The authors of this study conclude that it was indicated that at least in the hands of experienced surgeons doing about one case per week, good results can be achieved with the minimally-invasive oxford phase 3 medial unicompartmental knee replacement.

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 article was written by pandit h, et al in j bone joint surg br.2006 jan;88(1):54-60.It is likely that these complications and revisions 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 KNEE
• Type of Device: PROSTHESIS, 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: 4929602
• MDR Text Key: 16856045
• Report Number: 0001825034-2015-03174
• 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: Physician
• Type of Report: Initial
• Report Date: 07/01/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2015
• 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: 07/01/2015
• 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