MAUDE Adverse Event Report: BIOMET UK LTD. UNKNOWN OXFORD BEARING

Model Number N/A

Device Problems Mechanical Problem (1384); Device Dislodged or Dislocated (2923); Unintended Movement (3026)

Patient Problem Joint Dislocation (2374)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Initial report.Report source, foreign - event occurred in (b)(6).The client has indicated that the product will not be returned to zimmer biomet for an investigation.The investigation is currently underway.Once the investigation has concluded, a follow-up mdr will be tendered.

Event Description

Title: bearing separation from the lateral wall of the tibial component is a risk of anterior dislocation of the mobile-bearing in oxford unicompartmental knee arthroplasty.Authors: takafumi hiranaka, yoshihito suda, tomoyuki kamenaga, takaaki fujishiro, motoki koide, akira saitoh, atsuki tanaka, akihiko arimoto, koji okamoto.On 24-jan-2022, a journal article was retrieved from the journal of arthroplasty (2022) that reported a study from (b)(6) that looked at whether bearing separation from the lateral wall of the tibial component is a risk of anterior dislocation of the mobile-bearing in oxford unicompartmental knee arthroplasty.The study retrospectively analysed twelve-one dislocations in twelve patients which included the incidence of separation, the direction and the recurrence of the dislocations, and their causes.The study reported that five of the twelve patients had separation.Of the total of 21 dislocations, 11 occurred in cases of separation (52%).Seven out of 11 anterior dislocations were found to have separation, whereas nine out of 13 posterior dislocations occurred without separation (p = 0.0237).Three out of five patients with separation had a recurrence of dislocation, and eventually, two underwent revision to fixed-bearing uka.Case three: it was reported that a (b)(6) female patient underwent a revised bearing to +1 thickness due to dislocation which occurred while she was sleeping.

Event Description

On (b)(6) 2022.Title: bearing separation from the lateral wall of the tibial component is a risk of anterior dislocation of the mobile-bearing in oxford unicompartmental knee arthroplasty.Authors: takafumi hiranaka, yoshihito suda, tomoyuki kamenaga, takaaki fujishiro, motoki koide, akira saitoh, atsuki tanaka, akihiko arimoto, koji okamoto.On 24-jan-2022, a journal article was retrieved from the journal of arthroplasty (2022) that reported a study from japan that looked at whether bearing separation from the lateral wall of the tibial component is a risk of anterior dislocation of the mobile-bearing in oxford unicompartmental knee arthroplasty.The study retrospectively analysed twelve-one dislocations in twelve patients which included the incidence of separation, the direction and the recurrence of the dislocations, and their causes.The study reported that five of the twelve patients had separation.Of the total of 21 dislocations, 11 occurred in cases of separation (52%).Seven out of 11 anterior dislocations were found to have separation, whereas nine out of 13 posterior dislocations occurred without separation (p = 0.0237).Three out of five patients with separation had a recurrence of dislocation, and eventually, two underwent revision to fixed-bearing uka.Case six: it was reported that a 76-year-old female patient underwent two bearing revisions revised to +1 thickness due to dislocations that occurred while she was sleeping.

Manufacturer Narrative

(b)(4).Complaint summary: the product has not been returned for evaluation.The item and lot number have not been provided.X-rays or medical notes have not been provided.The investigation has been limited to the information provided.A historical search could not be performed as the item and lot number have not been provided.This device is used for treatment.Not enough information has been provided to determine if all implants are compatible.A dhr review or a review of recalls could not be performed as the item and lot number have not been provided.The likely condition of the device when it left zimmer biomet could not be determined as the item and lot number has not been provided.The root cause of the reported event can not be determined with the information provided.No corrective action is required at this time as the root cause of the reported event has not been determined.If any additional information is discovered or received that may adjust any conclusions or data, a supplemental report will be rendered accordingly.Zimmer biomet will continue to monitor for trends.

Manufacturer Narrative

(b)(4).Follow-up report that contains corrections.Fields corrected b5 and h10.G2: report source, foreign - event occurred in japan.D10: the client has indicated that the product will not be returned to zimmer biomet for an investigation.The investigation is currently underway.Once the investigation has concluded, a follow-up mdr will be tendered.

Event Description

(b)(6) 2022.Title: bearing separation from the lateral wall of the tibial component is a risk of anterior dislocation of the mobile-bearing in oxford unicompartmental knee arthroplasty.Authors: takafumi hiranaka, yoshihito suda, tomoyuki kamenaga, takaaki fujishiro, motoki koide, akira saitoh, atsuki tanaka, akihiko arimoto, koji okamoto.On (b)(6) 2022, a journal article was retrieved from the journal of arthroplasty (2022) that reported a study from japan that looked at whether bearing separation from the lateral wall of the tibial component is a risk of anterior dislocation of the mobile-bearing in oxford unicompartmental knee arthroplasty.The study retrospectively analysed twelve-one dislocations in twelve patients which included the incidence of separation, the direction and the recurrence of the dislocations, and their causes.The study reported that five of the twelve patients had separation.Of the total of (b)(4) dislocations, (b)(4) occurred in cases of separation (b)(4).(b)(4) anterior dislocations were found to have separation, whereas (b)(4) posterior dislocations occurred without separation (p = (b)(4)).Three out of five patients with separation had a recurrence of dislocation, and eventually, two underwent revision to fixed-bearing uka.Case six: it was reported that a 76-year-old female patient underwent two bearing revisions revised to +1 thickness due to dislocations that occurred while she was sleeping.

• Brand Name: UNKNOWN OXFORD BEARING
• Type of Device: UNKNOWN OXFORD BEARING
• 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: 13440262
• MDR Text Key: 289269275
• Report Number: 3002806535-2022-00043
• Device Sequence Number: 1
• Product Code: NRA
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Literature,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 03/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/03/2022
• 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: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/09/2022
• 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
• Patient Sex: Prefer Not To Disclose