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

Device Problem Insufficient Information (3190)

Patient Problem Debris, Bone Shedding (1803)

Event Type  Injury  

Manufacturer Narrative

Literature:romanowski mr, repicci ja minimally invasive unitcondylar arthroplasty (2002), pearse aj, hooper gj, rothwell a, survival and functional (2010).Product not available for evaluation.Without the opportunity to examine the complaint products, root causes 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.This report is being submitted late as it has been identified in remediation.

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" one (1) failure of the uka were identified in the article that underwent revisions due to excessive cement debris 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: PROTHESIS 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: 6996792
• MDR Text Key: 90886011
• Report Number: 0001825034-2017-09907
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/22/2015
• Was Device Evaluated by Manufacturer?: No
• 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): Required Intervention