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

Model Number N/A

Device Problem Metal Shedding Debris (1804)

Patient Problems Pain (1994); Patient Problem/Medical Problem (2688)

Event Date 12/04/2014

Event Type  Injury  

Manufacturer Narrative

(b)(4).From the investigations of device history records, deviation history and dimensional data collected concludes that the parts left biomet conforming.Review of device history records found these units were released to distribution with no deviations or anomalies.Review of complaint history found no additional issues reported for this part.There are warnings in the package insert that this type of event can occur and risks are addressed in risk documentation.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 patient underwent a left partial knee arthroplasty.Subsequently, patient was revised due to lateral progression and pain.Revision operative report noted the presence of lateral lesions, fluid and possible nickel allergy.All components were removed and replaced with a total knee system.

• Brand Name: OXF ANAT BRG LT SM 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: 6922318
• MDR Text Key: 88452686
• Report Number: 0001825034-2017-07994
• 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: 10/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2019
• Device Model Number: N/A
• Device Catalogue Number: 159541
• Device Lot Number: 014040
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/23/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/08/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/19/2014
• 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: 59 YR