MAUDE Adverse Event Report: BIOMET ORTHOPEDICS REPICCI TIBIAL 32X6.5MM; PROSTHESIS, KNEE

Model Number N/A

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem Pain (1994)

Event Type  Injury  

Event Description

Patient reported to have undergone partial knee arthroplasty on (b)(6) 2001.Patient alleges pain and that an mri revealed loose debris around the implant.There has been no reported revision procedure to date.A review of invoice history confirmed the initial surgery date.This report is based on allegations set forth in patient's complaint and the allegations contained therein are unverified.

Manufacturer Narrative

Current information is insufficient to permit a conclusion as to the cause of the event.Review of device history records show that lot released with no recorded anomaly or deviation.There are warnings in the package insert that state that this type of event can occur: under possible adverse effects, number 15 states, "intraoperative or postoperative bone fracture and/or postoperative pain." this report is based on allegations set forth in patient's complaint and the allegations contained therein are unverified.

• Brand Name: REPICCI TIBIAL 32X6.5MM
• Type of Device: PROSTHESIS, KNEE
• 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: amanda zajicek ; 56 e. bell drive; warsaw, IN 46582 ; 5743726782
• MDR Report Key: 3863572
• MDR Text Key: 15811586
• Report Number: 0001825034-2014-05292
• Device Sequence Number: 1
• Product Code: HRY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK980665
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 05/15/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 06/30/2006
• Device Model Number: N/A
• Device Catalogue Number: 102140
• Device Lot Number: 682550
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/15/2014
• Initial Date FDA Received: 06/10/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/22/2001
• 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