MAUDE Adverse Event Report: BIOMET UK LTD. OXFORD PKS CEMENTLESS TIBIA LEFT ALPHA POROUS/HA + EXTRACTOR SLOT LEFT MEDIAL SI; KNEE PROSTHESIS

Model Number N/A

Device Problem Unstable (1667)

Patient Problem Pain (1994)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: oxf anat brg lt md size 3 pma, item#159547, lot#6483393; oxford uni twin-peg femoral md, item#166942, lot#j6466714; palacos r+g 2x40g, item #66017569, lot #92804884.Report source foreign: (b)(6).Investigation of this incident is currently ongoing.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2022¿00286, 3002806535-2022¿00287, 3002806535-2022¿00288.

Event Description

It was reported that the patient underwent an initial left knee arthroplasty and approximately two (2) years post-implantation is still experiencing pain and instability.Due diligence is in progress for this complaint; to date no additional information has been received.

Event Description

No further event information available at the time of this report.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.No product was returned or pictures provided; visual and dimensional evaluations could not be performed to confirm reported event.The device history records for [item# 166574 lot# 3922603] identified no deviations during manufacturing related to the reported event.Devices are used for treatment.Medical records were not provided.A definitive root cause cannot be determined.

• Brand Name: OXFORD PKS CEMENTLESS TIBIA LEFT ALPHA POROUS/HA + EXTRACTOR SLOT LEFT MEDIAL SI
• Type of Device: KNEE PROSTHESIS
• 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: 14849602
• MDR Text Key: 295106956
• Report Number: 3002806535-2022-00287
• Device Sequence Number: 1
• Product Code: NRA
• UDI-Device Identifier: 00887868354731
• UDI-Public: (01)00887868354731(17)270402(10)3922603
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P010014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 07/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: 166574
• Device Lot Number: 3922603
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/15/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/19/2017
• 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
• Treatment: SEE H10 NARRATIVE
• Patient Outcome(s): Other
• Patient Sex: Female
• Patient Weight: 66 KG