MAUDE Adverse Event Report: ZIMMER BIOMET, INC. OXF ANAT BRG RT MD SIZE 3 PMA; PROSTHESIS, KNEE

Model Number N/A

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Arthritis (1723); Joint Dislocation (2374); No Code Available (3191)

Event Date 01/31/2011

Event Type  Injury  

Manufacturer Narrative

The product was not returned for evaluation as the product location is unknown.Review of device history records found these units were released to distribution with an unrelated deviation or anomaly.Review of complaint history identified additional complaints and following investigation, no further action was required.Without an opportunity to examine the product the complaint could not be confirmed and root cause cannot be determined.There are warnings in the package insert that this type of event can occur and risks are addressed in risk documentation, under possible adverse events, dislocation and subluxation due to inadequate fixation and improper positioning.Muscle and fibrous tissue laxity can also contribute to these conditions.Following review, no new risks were identified.(b)(4).This product is manufactured by zimmer biomet (b)(4) and is not cleared or distributed in the u.S.However, this report is being submitted as zimmer biomet (b)(4) manufactures a similar device that is cleared or distributed in the united states under pma number p010014.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 the patient underwent an initial partial knee arthroplasty on (b)(6)2009.Subsequently, the patient underwent a revision surgery to exchange the bearing of the right knee on (b)(6) 2011 due to dislocation.No further information has been provided.

• Brand Name: OXF ANAT BRG RT MD SIZE 3 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: 6970997
• MDR Text Key: 90029577
• Report Number: 0001825034-2017-09539
• 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: foreign,study
• Reporter Occupation: Physician
• 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: 10/24/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2013
• Device Model Number: N/A
• Device Catalogue Number: 159575
• Device Lot Number: 1519264
• Other Device ID Number: SEE H10
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/08/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/16/2008
• 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: 67 YR
• Patient Weight: 70