MAUDE Adverse Event Report: ZIMMER BIOMET, INC. OXF ANAT BRG RT MD SIZE 4 PMA; PROSTHESIS KNEE

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problem Death (1802)

Event Date 05/10/2015

Event Type  Death  

Manufacturer Narrative

Product was not returned to zimmer biomet.Without the opportunity to examine the complaint product, root cause cannot be determined.Review of device history records found unrelated deviations during the manufacturing process.The nonconformance was damage and it was scraped.Review of the complaint history identified additional complaints that were investigated, and it was determined that no further action is required due to no other parts from this lot with the same issue.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.

Event Description

It was reported a patient underwent right partial knee arthroplasty on (b)(6) 2007.Subsequently it was reported the patient expired due to unknown causes on(b)(6) 2015.

• Brand Name: OXF ANAT BRG RT MD SIZE 4 PMA
• 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: 6917818
• MDR Text Key: 88371198
• Report Number: 0001825034-2017-08010
• 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: distributor,health profession
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2012
• Device Model Number: N/A
• Device Catalogue Number: 159576
• Device Lot Number: 1392990
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/24/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/19/2007
• 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): Death
• Patient Age: 69 YR
• Patient Weight: 82