MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN KNEE; PROSTHESIS, KNEE

Model Number N/A

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Death (1802); Failure of Implant (1924); Pain (1994)

Event Type  Injury  

Event Description

Information was received based on review of a journal article titled, "the early radiological results of the uncemented oxford medial compartment knee replacement" which investigated the radiological outcomes of uncemented oxford medial compartment unicondylar replacements.The study was conducted over a period of three (3) years (may 2005 to september 2008) and involved two-hundred twenty (220) patients who received two-hundred thirty-one (231) knees.Five (5) patients deaths were reported unrelated to implants.The journal article reports the following revision by reason: one (1) revision due to pain and progressive radiolucency caused by tibial component failure due to inadequate impaction and failed settling with weight-bearing.The authors of the study conclude that the uncemented oxford ukr presents excellent functional results with significant improvement in the incidence of radiolucent lines.

Manufacturer Narrative

Current information is insufficient to permit conclusions as to the cause of the events.Event details and product identification was not provided for the patients mentioned in the journal article.(b)(6).

Manufacturer Narrative

Upon reassessment of the reported event, it was determined to be not reportable due to the device is not sold or distributed in the us; the event occurred in (b)(6).

Manufacturer Narrative

(b)(4).Upon review, it was determined that this report does meet the definition of a reportable complaint as the same/ or similar product was distributed in the united states.Customer has indicated that the product will not be returned to zimmer biomet for investigation reported event was unable to be confirmed due to limited information received from the customer.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.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

One (1) revision due to pain and progressive radiolucency caused by tibial component failure due to inadequate impaction and failed settling with weight-bearing.

• Brand Name: UNKNOWN KNEE
• 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: 4905950
• MDR Text Key: 6836980
• Report Number: 0001825034-2015-02983
• Device Sequence Number: 1
• Product Code: NRA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PUNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,foreign,literature
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 11/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/10/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: N/A
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/17/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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