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

Model Number N/A

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Wound Dehiscence (1154); Fall (1848)

Event Type  Injury  

Event Description

It was reported, that: on 13 oct 2021, a journal article was retrieved by our clinical team from the journal of arthroscopy and joint surgery that reported a study from china.The objective of this study was to compare the short-term clinical outcomes and rate of residual bone cement extrusion between hybrid and cemented prostheses and analyse the possible reasons for differences between outcomes.A total of 128 knees (118 patients) with end-stage osteoarthritis were included in this study, of which underwent consecutive operations using unicondylar oxford phase 3 implants from july 2017 and september 2019.Follow-up was performed at 6 weeks, 3 and 6 months, 1 year and every year after the operation, and complications and changes in the oxford knee score (oks) were recorded.Our study results showed that hybrid ouka can produce short-term postoperative results as successful as those of cemented prostheses for treating end-stage medial unicompartmental osteoarthritis of the knee.The application of hybrid prostheses and a strategy of multiple removals of excess bone cement result in a reduction of bone cement residue around the tibial prosthesis.Complaint two: the study reports that a patient had skin incision dehiscence 3 months after the operation due to a fall and healed following debridement.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 china.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: 3002806535-2022-00127 and 3002806535-2022-00128.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 FEMORAL
• 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: 13823661
• MDR Text Key: 291836070
• Report Number: 3002806535-2022-00129
• Device Sequence Number: 1
• Product Code: NRA
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2022
• 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 FEMORAL
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/13/2021
• 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