MAUDE Adverse Event Report: BIOMET UK LTD. UNKNOWN OXFORD FEMORAL COMPONENT

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Altay o.Altuntas, helen alsop, justin p.Cobb.(2013)"early results of a domed tibia, mobile bearing lateral unicompartmental knee arthroplasty from an independent centre.The knee volume 20, issue 6, december 2013, pages 466-470, http://www.Sciencedirect.Com/science/article/pii/s096801601200230x?via%3dihub.(b)(6).Reported event was unable to be confirmed due to limited information received from the customer.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.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

Information received based on review of a journal article, entitled "early results of a domed tibia, mobile bearing lateral unicompartmental knee arthroplasty from an independent centre" by altay o.Altuntas et al.(2012) this complaint refers to the reported an arthroscopic washout performed 4 weeks post primary surgery, due to haemarthrosis (bleeding into the joint)."one patient had a haemarthrosis and required arthroscopic washout.His function improved by 13 (from 26 to 39) at 21 months." - page 468.

• Brand Name: UNKNOWN OXFORD FEMORAL COMPONENT
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• Manufacturer (Section G): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 7178188
• MDR Text Key: 96836190
• Report Number: 3002806535-2018-00051
• Device Sequence Number: 1
• Product Code: KXA
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: PN/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/10/2018

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: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/21/2017
• Initial Date FDA Received: 01/10/2018
• 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