MAUDE Adverse Event Report: BIOMET UK LTD. UNKNOWN OXFORD BEARING; PROSTHESIS, KNEE

Model Number N/A

Device Problem Unintended Movement (3026)

Patient Problem Joint Dislocation (2374)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Long-term clinical results of unicompartmental knee arthroplasty in patients younger than 60 years of age: minimum 10-year follow-up kyung tae kim, md, song lee, md, jung soo lee, md, min su kang, md, and ki hyuk koo, md (2018) report source foreign - (b)(6).As limited information was received from the customer, the reported events could not be confirmed.As the lot numbers of the devices are unknown, dhr reviews could not be performed.Root cause could not be determined.If further information is found that would change or alter any conclusions reached, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor trends.

Event Description

Information received based on journal article "long-term clinical results of unicompartmental knee arthroplasty in patients younger than 60 years of age: minimum 10-year follow-up¿ by kyung take kim et al (2018).Abstract purpose: to evaluate the long-term clinical results and survivorship of unicompartmental knee arthroplasty (uka) in patients younger than 60 years of age.Materials and methods: one hundred and six cases of medial uka with a minimum follow-up of 10 years were selected for this study.There were 80 patients and the preoperative diagnosis was osteoarthritis in all cases.The mean age of the patients was 54.2 years and the mean duration of followup was 12.1 years.Clinical assessments were performed using the knee society clinical rating system, and a survival analysis was performed using the kaplan-meier method.Results: the mean knee and function scores improved from 52.8쳌}8.4 points and 56.6쳌}10.6 points preoperatively to 85.4쳌}9.1 points and 84.7쳌}10.4 points at the last follow-up, respectively (p<0.001).The mean range of motion was recovered from 130.7° to 132.8° at the last follow-up.Complications occurred in 20 cases (16.7%) and the most prevalent complication was mobile bearing dislocation (n=9, 7.5%).The 10-year survival rate was 92.8% when conversion to total knee arthroplasty was defined as failure, whereas 89.3% when failure was defined as all revision surgeries.Conclusions: the long-term clinical results of uka were satisfactory in patients under 60 years of age.Therefore, uka could be a useful method for the treatment of medial compartment osteoarthritis of the knee in patients younger than 60 years of age.This complaint refers to line item 1 of table 3: 6 conversion from uka to tka due to bearing dislocation.

• Brand Name: UNKNOWN OXFORD BEARING
• Type of Device: PROSTHESIS, KNEE
• 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: 7344449
• MDR Text Key: 102578080
• Report Number: 3002806535-2018-00482
• Device Sequence Number: 1
• Product Code: NRA
• Combination Product (y/n): N
• Reporter Country Code: KS
• 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: 03/16/2018

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
• Device Model Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/21/2018
• Initial Date FDA Received: 03/16/2018
• 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