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

Device Problem Loss of or Failure to Bond (1068)

Patient Problem No Information (3190)

Event Type  Injury  

Manufacturer Narrative

Literature: goodfellow, j.W., & oconnor, j.(1986).Clinical results of the oxford knee.Clinical orthopaedics and related research, &na;(205).Doi:10.1097/00003086-198604000-00005.The product was not available for return.Without the opportunity to examine the complaint device, root cause cannot be determined.Part and lot identification are necessary for review of device history records and complaint history, neither were provided.The condition is addressed in package insert.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.Zimmer biomet complaint: (b)(4).

Event Description

Information was received based on review of a journal article entitled, "clinical results of the oxford knee: surface arthroplasty of the tibiofemoral joint with a meniscal bearing prosthesis".This complaint addresses two (2) knees that required a revision due to loosening of tibial components.There has been no further information provided and the patients outcome is unknown.

• 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: 7040283
• MDR Text Key: 92294419
• Report Number: 0001825034-2017-10371
• Device Sequence Number: 1
• Product Code: NRA
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: PN/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 11/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2017
• 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?: Yes
• Date Manufacturer Received: 06/18/2015
• 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