MAUDE Adverse Event Report: BIOMET UK LTD. UNKNOWN OXF TIBIAL

Model Number N/A

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Damage to Ligament(s) (1952)

Event Type  Injury  

Event Description

It was reported, that: on 14 sep 2021, a journal article was retrieved by our clinical team that reported a study from (b)(6) which looked at the effect of changes taking place on the tibial slope of cementless unicondylar knee arthroplasties and defined its relationship with functional scores.This study analysed the patients undergoing a cementless unicondylar knee arthroplasty between january 2011 and july 2019.Overall, 161 cases were included.Patients were analyzed using standard radiographs for changes in pts, coronal positioning of the implant, and overhanging.This study showed that, with time, minimal changes take place in the pts of cementless unicondylar knee arthroplasty.The change mostly takes place during the first 6 months.These changes do not affect functional scores.Complaint three: the study reports intraoperative damage to the medial collateral ligament in two patients.Patient outcome: serious injury.

Manufacturer Narrative

(b)(4).This is a combined initial/final report and is being submitted to relay information.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.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.A historical search could not be performed as the item and lot number have not been provided.This device(s) 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.Unable to perform previous field action search as the item and lot number have not been provided.The likely condition of the device(s) when it/they 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.Multiple mdr reports were filed for this event, please see associated report numbers: 3002806535-2022-00142, 3002806535-2022-00144.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.

• Brand Name: UNKNOWN OXF TIBIAL
• Type of Device: UNKNOWN OXF
• 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: 13859299
• MDR Text Key: 287665029
• Report Number: 3002806535-2022-00143
• Device Sequence Number: 1
• Product Code: NRA
• Combination Product (y/n): N
• Reporter Country Code: TU
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2022
• 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 OXF TIBIAL
• 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: 09/14/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention