MAUDE Adverse Event Report: BIOMET ORTHOPEDICS UNKNOWN 79MM REGENEREX TIBIAL BASEPLATE; PROSTHESIS

Model Number N/A

Device Problem Fracture (1260)

Patient Problems Pain (1994); Limited Mobility Of The Implanted Joint (2671)

Event Date 02/01/2013

Event Type  Injury  

Manufacturer Narrative

Customer has indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Stormont, et al." catastrophic failure of regenerex tibial components: a case series" the journal of knee surgery.Doi http://dx.Doi.Org/10.1055/s-0036-1593876.

Event Description

It is reported in a journal article that the patient presented with pain, limp, and limited range of motion in (b)(6) 2013.It was confirmed through x-ray that the tibial baseplast had fractured on the medial side and medial subsidence had occurred.The patient was revised due to the fracture and subsidence with metallosis being noted during the revision procedure.

Manufacturer Narrative

This report is a duplicate of 0001825034-2016-05407.The initial report was submitted in error and should be voided.

• Brand Name: UNKNOWN 79MM REGENEREX TIBIAL BASEPLATE
• Type of Device: PROSTHESIS
• Manufacturer (Section D): BIOMET ORTHOPEDICS; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): BIOMET ORTHOPEDICS; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 6378567
• MDR Text Key: 69094812
• Report Number: 0001825034-2017-01346
• Device Sequence Number: 1
• Product Code: NPJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PN/I
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/03/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/01/2017
• 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
• Patient Age: 60 YR