MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN REPICCI II RESURFACING KNEE SYSTEM

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Joint Disorder (2373)

Event Type  Injury  

Manufacturer Narrative

Zimmer biomet complaint: (b)(4).This report is being submitted late as it has been identified in remediation.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) and complaint history review was unable to be performed as the part and 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.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.Odonnell, t.M., abouazza, o., & neil, m.J.(2013).Revision of minimal resection resurfacing unicondylar knee arthroplasty to total knee arthroplasty.The journal of arthroplasty, 28(1), 33-39.Doi:10.1016/j.Arth.2012.02.031.

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" twelve (12) failure of the uka were identified in the article that underwent revisions due to progression of disease to other compartments on an unknown date.There has been no further information provided and the patient outcome is unknown.

• Brand Name: UNKNOWN REPICCI II RESURFACING KNEE SYSTEM
• 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: 7002925
• MDR Text Key: 91082725
• Report Number: 0001825034-2017-09939
• Device Sequence Number: 1
• Product Code: NRA
• Combination Product (y/n): N
• Reporter Country Code: EI
• PMA/PMN Number: PNI
• 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: 11/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/06/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• 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 This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention