MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN KNEE; PROSTHESIS, KNEE

Model Number N/A

Device Problems Fracture (1260); Loose or Intermittent Connection (1371); Material Rupture (1546); Device Operates Differently Than Expected (2913); Device Dislodged or Dislocated (2923); Insufficient Information (3190)

Patient Problems Death (1802); Unspecified Infection (1930); Necrosis (1971); Pain (1994)

Event Type  Injury  

Event Description

Information was received based on review of a journal article titled, "does body mass index affect the outcome of unicompartmental knee replacement?" which aimed to assess the impact of bmi on the clinical outcome and mid/long term survival of a large series of oxford phase 3 ukrs (manufactured at biomet) performed in two centres to determine if mbi should be considered to be a contraindication to ukr.This study consisted of 2438 knees identified with nine lost to follow-up.The mean age of the patients at the time of surgery was (b)(6).There were 63 re-operations that were classified as failures: 18 for unexplained pain, 18 for component loosening, eight for progression of osteoarthritis in the lateral compartment, eight for bearing dislocations, seven for infection, two for fracture, one for traumatic anterior cruciate ligament rupture and one for avascular necrosis of the lateral femoral condyle.There was a significant negative correlation between the bmi at surgery and the patient's age at surgery with the patient needing a ukr at a younger age with increasing bmi.Sub-groups bmi less than 25, 378 knees.69 years old at time of surgery.9 knees revised: 3 pain, 2 infection, 1 progression of osteoarthritis in the lateral compartment, 1 aspetic loosening, and 1 bearing dislocation.Bmi 25 to less than 30, 856 knees, 65 years old, 25 revisions: 7 pain, 5 aseptic loosening, 4 infection, 3 progression of osteoarthritis, 3 bearing dislocation, 1 traumatic acl rupture, 1 avn of the lateral femoral condyle, 1 fracture.Bmi 30 to less than 35, 712 knees, 61 years old, 18 revisions: 6 pain, 5 aspetic loosening 3 progression of oa, 3 bearing dislocation, 1 peri-prosthetic fracture.Bmi 35 to less than 40, 286 knees, 61 years old, 7 revised: 4 aseptic loosening, 1 pain, 1 infection, 1 bearing dislocation bmi 40 to less than 45, 126 knees, 58 years old, 4 revised: 2 aseptic loosening, 1 pain, 1 infection.Bmi greater than or equal to 45, 80 knees, 59 years old, no revisions.In conclusion, this study is more than an order of magnitude larger than previous studies of bmi in ukr.It demonstrates that the survival rate of the oxford knee does not decrease with increasing bmi, even with bmis as high as 45-50.Therefore, a high bmi should not be considered a contraindication to surgery.The benefit, in terms of improved pain and function, resulting from a ukr, increases with increasing bmi.Therefore, obese patients should not be denied a ukr for fear of a poor outcome.An unspecified number of the nine patients lost to follow-up died due to unknown reasons.

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.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.

Manufacturer Narrative

Without the opportunity to examine the complaint product, root cause cannot be determined.Part and lot identification are necessary for review of device history records and complaint history, neither were provided.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: UNKNOWN KNEE
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 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: 4905774
• MDR Text Key: 17580960
• Report Number: 0001825034-2015-02979
• 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,foreign,literature
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• 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
• Initial Date Manufacturer Received: 06/18/2015
• Initial Date FDA Received: 07/10/2015
• Supplement Dates Manufacturer Received: 06/18/2015
• Supplement Dates FDA Received: 11/09/2017
• 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