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

Model Number N/A

Device Problems Migration or Expulsion of Device (1395); Device Slipped (1584)

Patient Problems Bone Fracture(s) (1870); Necrosis (1971); Test Result (2695); No Code Available (3191)

Event Type  Injury  

Event Description

Information was received based on review of a journal article entitled, "revision of minimal resection resurfacing unicondylar knee arthroplasty to total knee arthroplasty" which compared patients undergoing revision of minimal resection resurfacing uka to tka with patient undergoing primary tka.The study was conducted over a period of five (5) years (2003 to 2008) and involved fifty-five (110) patients who received fifty-five (55) tkas revised from ukas (forty-two (42) biomet uka and thirteen (13) competitor uka), and fifty-five (55) primary tkas with competitor products.The journal article reports the following uka revisions by reason: thirty-two (32) revisions due to baseplate subsidence.Twelve (12) revisions due to progression of disease to other compartments.Five (5) revisions due to stress fracture of the tibia.Four (4) revisions due to aseptic loosening.One (1) revision due to avascular necrosis of the femoral condyle.One (1) revision due to excessive cement debris.The authors of the study conclude that there is no significant difference between the two groups in terms of range of motion, functional outcome, or radiologic outcomes.Revision of these types of implants to tka is associated with similar results to primary tka and is superior to revision of other forms of uka.

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 o'donnell tm, abouazza o, neil mj in j arthroplasty.2013 jan;28(1):33-9.Doi: 10.1016/j.Arth.2012.02.031.

Manufacturer Narrative

(b)(4).This supplemental report is being submitted to address only one event of the article.The following fields have been updated with additional/ updated information.Event description, patient/ device codes, evaluation codes, manufacturer narrative.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 was 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 failure of the uka were identified in the article that underwent revisions due to aseptic loosening 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 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: 4916529
• MDR Text Key: 16561541
• Report Number: 0001825034-2015-03006
• Device Sequence Number: 1
• Product Code: NRA
• Combination Product (y/n): N
• Reporter Country Code: EI
• 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: 11/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2015
• 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: 06/22/2015
• 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