MAUDE Adverse Event Report: ZIMMER BIOMET, INC. OXF PKS ANAT MEN BRG UHMWPE RT SML SZ 3; PROSTHESIS, KNEE

Model Number N/A

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Cyst(s) (1800); Debris, Bone Shedding (1803)

Event Date 10/08/2015

Event Type  Injury  

Manufacturer Narrative

Zimmer biomet complaint-(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation as it was discarded.Reported event was unable to be confirmed due to limited information received from the customer.Dhr was reviewed and no discrepancies were found.Review of the complaint history determined that no further action is required as no were trends identified.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

It was reported that patient took part in oxford minimum 5 year study.The patient was revised to a total knee due to lateral progression, osteophytes, bone cysts, eburnated bone, and bone loss.

• Brand Name: OXF PKS ANAT MEN BRG UHMWPE RT SML SZ 3
• 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: 7121992
• MDR Text Key: 95003940
• Report Number: 0001825034-2017-11215
• Device Sequence Number: 1
• Product Code: NRA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PP010014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/01/2013
• Device Model Number: N/A
• Device Catalogue Number: 159568
• Device Lot Number: 526944
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/12/2016
• Initial Date FDA Received: 12/15/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/04/2008
• 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
• Patient Age: 77 YR
• Patient Weight: 72