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

Model Number N/A

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Information (3190)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Kenjiro yoshida, md , masahiro tada, md, phd , hirokazu yoshida, md , satoshi takei, md, shinichi fukuoka, md, phd , hiroaki nakamura, md, phd "oxford phase 3 unicompartmental knee arthroplasty in japan ¿ clinical results in greater than one thousand cases over ten years", the journal of arthroplasty 28 suppl.2 (2013) 168¿171 https://www.Sciencedirect.Com/science/article/pii/s088354031300630x?via%3dihub report source, foreign - event occurred in (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 journal article entitled "oxford phase 3 unicompartmental knee arthroplasty in japan ¿ clinical results in greater than one thousand cases over ten years", by kenjiro yoshida, et al.(2013) abstract there are few reports of the oxford unicompartmental knee arthroplasty (uka) survival rate in asia.This study describes outcomes of 1279 oxford ukas for japanese patients.The mean follow-up was 5.2 years.We divided patients into two groups based on preoperative indications (extended indications group and strict indications group).The oxford knee score improved from 22.3 to 40.8 (p = 0.041).The 10-year survival rate using revision was 95%.A total of 25 ukas (2.0%) required revision.The most common reason was subsidence of tibial component.The 5-year cumulative survival rate of the strict indications group was significantly higher than that of the extended indications group (99.1% vs.93.8%, p b 0.001).When we followed inclusion criteria strictly, good clinical results were achieved in asia.This complaint refers to the case 23 reported in table 3, page 170.It was reported that the patient underwent oxford knee revision due to subsidence of tibial component.Operative findings:smaller tibial component.Revised to tka.

• Brand Name: UNKNOWN OXFORD TIBIAL 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: 7245169
• MDR Text Key: 99183049
• Report Number: 3002806535-2018-00238
• Device Sequence Number: 1
• Product Code: HRY
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 02/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/23/2018
• 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