UNKNOWN PARTIAL KNEE N/A

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2012-04-16 for UNKNOWN PARTIAL KNEE N/A manufactured by Biomet U.k..

Event Text Entries

[16006980] Implanted date - (b)(6) 2009. The product and lot identification necessary to review manufacturing history was not provided. Current information is insufficient to permit a conclusion as to the cause of the event. There are warnings in the package insert that state that this type of event can occur: under possible adverse effects, number ten states, "loosening or migration of the implants can occur due to loss of fixation, trauma, malalignment, bone resorption, and excessive activity". Number twenty states, "persistent pain".
Patient Sequence No: 1, Text Type: N, H10

[16123318] It was reported that patient underwent partial knee arthroplasty in (b)(6) 2009. Subsequently, the patient had the knee scoped to remove loose cement in (b)(6) 2011. The patient was revised from a partial knee to a complete knee on (b)(6) 2011, due to pain and instability.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 0001825034-2012-00454
• MDR Report Key: 2535905
• Report Source: 00
• Date Received: 2012-04-16
• Date of Report: 2012-03-19
• Date Mfgr Received: 2012-03-19
• Date Added to Maude: 2012-04-16
• Event Key: 0
• Report Source Code: Manufacturer report
• Manufacturer Link: Y
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Reporter Occupation: PATIENT
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 0
• Event Location: 0
• Manufacturer Contact: MS. ANGELA DICKSON
• Manufacturer Street: 56 E. BELL DRIVE
• Manufacturer City: WARSAW IN 46582
• Manufacturer Country: US
• Manufacturer Postal: 46582
• Manufacturer Phone: 5743711021
• Manufacturer G1: BIOMET ORTHOPEDICS
• Manufacturer Street: 56 E. BELL DRIVE
• Manufacturer City: WARSAW IN
• Manufacturer Country: US
• Single Use: 3
• Previous Use Code: 3
• Removal Correction Number: N/A
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: UNKNOWN PARTIAL KNEE
• Generic Name: PROSTHESIS, KNEE
• Product Code: BTK
• Date Received: 2012-04-16
• Model Number: N/A
• Catalog Number: UNKNOWN
• Lot Number: UNKNOWN
• ID Number: N/A
• Operator: PHYSICIAN
• Device Availability: N
• Device Eval'ed by Mfgr: R
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: BIOMET U.K.
• Manufacturer Address: WATERTON INDUSTRIAL ESTATE BRIDGEND UK

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Hospitalization; 2. Required No Informationntervention	2012-04-16