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

Model Number N/A

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Joint Dislocation (2374)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Kyung tae kim, md, song lee, md, jee hyoung kim, md, sung won hong, md, woo shik jung, md, won shik shin, md the survivorship and clinical results of minimally invasive unicompartmental knee arthroplasty at 10-year follow-up clinics in orthopedic surgery 2015;7:199-206 ¿ http://dxd.Oi.Org/10.4055/cios.2015.7.2.199.Report source, foreign - events occurred in (b)(6).Reported event was unable to be confirmed due to limited information received from the customer.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 for trends.

Event Description

Information received based on journal article entitled "the survivorship and clinical results of minimally invasive unicompartmental knee arthroplasty at 10-year follow-up", by kyung tae kim, et al.(2014) abstract background: in this study, we investigated the long-term clinical results and survival rate of minimally invasive unicompartmental knee arthroplasty (uka) by collecting cases that had been implanted more than 10 years ago.Methods: one hundred and twenty-eight patients (166 cases) who underwent oxford phase 3 medial uka using the minimally invasive surgery from january 2002 to december 2002 were selected.The mean age of the patients at the time of surgery was 61 years, and the duration of the follow-up was minimum 10 years.Clinical and radiographic assessments were performed using the knee society clinical rating system, and the survival analysis was done by the kaplan-meier method with 95% confidence interval (ci).Results: the mean knee society knee and function scores improved significantly from 53.8 points (range, 25 to 70 points) and 56.1 points (range, 35 to 80 points) preoperatively to 85.4 points (range, 58 to 100 points) and 80.5 points (range, 50 to 100 points) at 10-year follow-up, respectively (p < 0.001).Failures following the uka occurred in 16 cases (9.6%), and the mean time of the occurrence of the failure was 6.2 years after the surgery.The 10-year survival rate was 90.5% (95% ci, 85.9 to 95.0) when failure was defined as all the reoperations, whereas the 10-year survival rate was 93.4% (95% ci, 89.6 to 97.1) when the cases in which only revision total knee arthroplasty was defined as failure.Conclusions: the results of this study show outstanding functions of the knee joint and satisfactory 10-year survival rate after minimally invasive uka.Therefore, minimally invasive uka could be a useful method in the treatment of osteoarthritis in one compartment of knee joint.This complaint refers to one knee revision due to components loosening and bearing dislocation (page 202, table 3.) ¿in one of the cases in which dislocation of mobile-bearing occurred, loosening of the femoral and tibial implants was detected intraoperatively while treating the dislocation of mobile-bearing that occurred after 6 years and 9 months of the surgery, although the loosening of the implant was not detected under the radiographic image at the time of the follow-up examination.This case was treated by means of revision tka.¿.

• 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: 7267292
• MDR Text Key: 99935919
• Report Number: 3002806535-2018-00286
• Device Sequence Number: 1
• Product Code: HRY
• 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: 02/13/2018

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
• Device Catalogue Number: UNKNOWN OXFORD BEARING
• Device Lot Number: NOT REPORTED
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/23/2018
• Initial Date FDA Received: 02/13/2018
• 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