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

Model Number N/A

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Failure of Implant (1924)

Event Type  Injury  

Event Description

It was reported, that: on (b)(6) 2021, a journal article was retrieved by our clinical team that reported a study from the (b)(6) which looked at the effect of age on the outcomes of cementless mobile-bearing unicompartmental knee replacements.This study analysed the effect of age at the surgery on the mid to long term clinical outcomes of 1000 cementless ukr.Patients were categorised into four age groups (< 55, 55 to < 65, 65 to < 75 and = 75 years).Implant survival was assessed using endpoints reoperation, revision and major revision requiring revision knee replacement components.Functional outcomes were assessed.Complaint five: the study reports revision (tkr) due to tibial plateau fracture.Patient outcome: revision.

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).Concomitant medical products: 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.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: 13861019
• MDR Text Key: 292797461
• Report Number: 3002806535-2022-00162
• Device Sequence Number: 1
• Product Code: NRA
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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

• 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
• Initial Date Manufacturer Received: 09/08/2021
• Initial Date FDA Received: 03/23/2022
• 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): Required Intervention; Hospitalization