MAUDE Adverse Event Report: ZIMMER BIOMET, INC. OXF ANAT BRG LT SM SIZE 3 PMA; PROTHESIS KNEE

Model Number N/A

Device Problem Loose or Intermittent Connection (1371)

Patient Problems Bruise/Contusion (1754); Death (1802)

Event Date 10/15/2015

Event Type  Death  

Manufacturer Narrative

Product was not retuned to zimmer biomet.Not cleared for distribution in the u.S.Without the opportunity to examine the complaint product, root cause cannot be determined.Review of the complaint history identified additional complaints that were investigated, and it was determined that no further action is required due to there is no indication that the events including the death is related to the implants.Review of device history records found a deviation during the manufacturing process.The nonconformance was one piece was scrapped for inclusion for both manufacturing processes of parts 159540 and 159569.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 that the clinical patient had an initial right oxford knee procedure on (b)(6) 2007 and an initial left oxford knee procedure on (b)(6) 2007.Patient reported on (b)(6) 2007 of severe bruising on left knee after uka which was resolved by (b)(6) 2008.Patient reported on (b)(6) 2008 of an old left ankle fracture.Patient reported on an unknown date in 2011 of a possible loose body in the left knee and of left knee locking that was resolved by (b)(6) 2012.Patient reported on (b)(6) 2012 of two fractured vertebrae in the past and of osteoporosis of the vertebrae.Patient was reported to have expired on (b)(6) 2015 of unknown causes with implants believed to be in situ.

• Brand Name: OXF ANAT BRG LT SM SIZE 3 PMA
• Type of Device: PROTHESIS 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: 6918081
• MDR Text Key: 88371769
• Report Number: 0001825034-2017-08044
• Device Sequence Number: 1
• Product Code: NRA
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: PP010014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• 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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2011
• Device Model Number: N/A
• Device Catalogue Number: 159540
• Device Lot Number: 1207381
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/22/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/03/2006
• 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: 90 YR
• Patient Weight: 74