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

Device Problem Inadequacy of Device Shape and/or Size (1583)

Patient Problem No Information (3190)

Event Type  Injury  

Manufacturer Narrative

Kort, n.P., jos j.A.M.Van raay, & horn, j.J.(2006).The oxford phase iii unicompartmental knee replacement in patients less than 60 years of age.Knee surgery, sports traumatology, arthroscopy, 15(4), 356-360.Doi:10.1007/s00167-006-0204-9.The product was not available for return.Without the opportunity to examine the complaint product, root cause cannot be determined.Part and lot identification are necessary for review of device history records and complaint history, neither were provided.Risks associated with reported condition are addressed through the warnings in the package insert as a part of design control risk management.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

Six (6) patients were identified in the article that had a 1¿2 mm overhang of the tibial component on the medial side on an unknown date following a unicompartmental knee arthroplasty (uka).It was further reported that the overhang of six tibia plateaus may also be considered as a technical failure.All cases are asymptomatic, but only further follow-up can provide information with regard to the importance of this finding.There has been no further information provided.

• Brand Name: UNKNOWN OXFORD 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: 6968056
• MDR Text Key: 89922862
• Report Number: 0001825034-2017-09532
• Device Sequence Number: 1
• Product Code: NRA
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: PUNKNOWN
• 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: 10/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2017
• 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?: Yes
• Date Manufacturer Received: 06/30/2015
• 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): Other