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

Model Number N/A

Device Problems Device Slipped (1584); Device Dislodged or Dislocated (2923); Insufficient Information (3190)

Patient Problems Bone Fracture(s) (1870); Unspecified Infection (1930); Inflammation (1932); Laceration(s) (1946); Patient Problem/Medical Problem (2688); Fibrosis (3167)

Event Type  Injury  

Event Description

Information was received based on review of a journal article titled, "mobile versus fixed bearing medial unicompartmental knee arthroplasty: a series of 375 patients".This study aimed to compare outcomes, complications and survival between mobile and fixed bearing medial unicompartmental knee arthroplasty (uka) in a large multi-surgeon group which used the oxford manufactured at biomet.This study consisted of 375 unicompartmental knee arthroplasties performed from march 2003 to august 2012 by 12 surgeons.Of the 375 medial ukas that were performed, 308 were mobile bearing and 67 were fixed bearing.All mobile bearing components were the oxford, performed by 10 surgeons.The 67 fixed bearings designs were competitor product performed by various surgeons.Average age at time of implantation was 62 years in mobile and 59 nears in fixed.Average follow-up was 47 months.Complications occurred in 20 mobile bearing and 5 fixed bearing.The most common complications in mobile bearing implants were progression of lateral compartment disease and component loosening.Overall survivorship was 94.8% in mobile.There were 7 patients with progression of lateral compartment disease, 4 component loosening, 3 bearing dislocation, 2 tibial plateau fractures, 1 infection, 1 arthrofibrosis, 1 implant subsidence without fracture, and 1 inflammatory synovial disease progression.Revision occurred in 16 mobile bearing implants.Bearing dislocation resulted in simple poly exchange in 2 cases.The other 14 ukas required conversion to total knee arthroplasty for the following reasons: progression of lateral compartment disease in 4 patients, 4 component loosening, 2 tibial plateau fractures, 1 infection, 1 repeat bearing dislocation, 1 component subsidence, and 1 inflammatory synovial disease progression.The other four complications underwent return trips to the operating room for manipulation under anesthesia in one patient, and 3 arthroscopic debridements of lateral meniscal tear and loose body removal.In conclusion, component loosening has been proposed to be one of the leading causes of conversion to tka.In mobile bearing implants, the motion and shear force transmission from the mobile bearing interface should theoretically lead to low rates of component loosening.

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.Initial reporter - the article was written by robert f murphy in reconstructive review: volume 5, number 1, march 2015.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

(b)(4).This follow-up report is being submitted to relay additional information.This report is to address only one event of the article.Customer has indicated that the product will not be returned to zimmer biomet for investigation.Reported event was unable to be confirmed due to limited information received from the customer.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.Root cause is suspected to be due to patient condition; additional root causes are unable to be determined as the necessary information to adequately investigate the reported event was not provided.There are warnings in the package insert that this type of event can occur and risks are addressed in risk documentation.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.This report is being submitted late as it has been identified in remediation.

Event Description

Four (4) patients were identified in the article with lateral compartment disease progression, were converted to tka on an unknown date.There has been no further information provided and the patient outcome is unknown.All other events will be reported in individual records which will be linked to this parent record.

• 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): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 4851590
• MDR Text Key: 20070199
• Report Number: 0001825034-2015-02638
• Device Sequence Number: 1
• Product Code: NRA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PN/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,literature
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/17/2015
• 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 KNEE
• 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: 06/12/2015
• 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