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) refer to attached journal article: does new instrumentation improve radiologic alignment of the oxford® medial unicompartmental knee arthroplasty? ki-mo jang a, hong chul limb, seung-beom han a, chandong jeong c, seul-gi kima, ji-hoon bae the knee 24 (2017) 641¿650 (elsevier) report source, foreign - events occurred in (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 a review of the journal article entitled "does new instrumentation improve alignment of the oxford medial unicompartmental knee arthroplasty?" by ki-mo jang, et al.(2017) abstract background: a new instrument system has been introduced to improve the accuracy and reproducibility of implant positioning in oxford® unicompartmental knee arthroplasty (uka).This study aimed to determine if the new instrumentation could improve postoperative implant positioning and limb alignment, and reduce the occurrence of outliers in oxford® uka.Methods: a total of 77 cases of oxford® uka with the new instrumentation were included.Individual matching for the conventional instrument group was performed according to age, sex, and body mass index.Postoperative radiological variables, including the hip-knee-ankle angle and the varus/valgus and flexion/extension angles of the femoral and tibial implants, were measured and compared between the new instrumentation group and the conventional group.The outliers in implant positions and postoperative complications were also compared.Results: no significant between-group differences were observed in terms of lower limb alignment and tibial implant alignment.However, statistically significant differences were identified in the varus/valgus and flexion/extension angles of the femoral implant (p = 0.01 and p b 0.001, respectively).More outliers were observed in the flexion/extension angles of the femoral and tibial implants in the new instrumentation group.Eight meniscal bearing dislocations and three lateral compartmental degenerative changes were found in the conventional group, while there were two meniscal bearing dislocations in the new instrumentation group during the study period.Conclusion: the present study did not confirm any benefit of the new instrument system in terms of postoperative limb alignment, positioning of the implant, or reducing outliers beyond the use of the conventional instruments.This complaint refers to the 2 meniscal bearing dislocations found in the new instrumentation group.All dislocation cases were treated using bearing change (one for the new instrumentation group) or revision to total knee arthroplasty (one for the new instrumentation group).(page 647).

• 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: 7288280
• MDR Text Key: 100651180
• Report Number: 3002806535-2018-00387
• 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,literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2018
• 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
• Date Manufacturer Received: 02/03/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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