MAUDE Adverse Event Report: BIOMET UK LTD. OXFORD PKS ANATOMIC ARCOM MENISCAL BEARING MEDIUM LEFT SIZE 3; KNEE PROSTHESIS

Model Number N/A

Device Problem Unstable (1667)

Patient Problem Pain (1994)

Event Type  Injury  

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.

Manufacturer Narrative

(b)(4).Concomitant medical products: oxf uni cmntls tib sz c lm item#166574 lot#3922603, oxford uni twin-peg femoral md item#166942 lot#j6466714, palacos r+g 2x40g item #66017569 lot #92804884.Report source: (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 ¿ 00287, 3002806535 - 2022 ¿ 00288.

Event Description

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

Manufacturer Narrative

No product was returned or pictures provided; visual and dimensional evaluations could not be performed to confirm reported event.Review of the device history record (mhr item# 159547 lot# 6483393) identified no deviations or anomalies during manufacturing.Devices are used for treatment.Medical records were not provided.A definitive root cause cannot be determined.

• Brand Name: OXFORD PKS ANATOMIC ARCOM MENISCAL BEARING MEDIUM LEFT SIZE 3
• 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: 14849593
• MDR Text Key: 294909695
• Report Number: 3002806535-2022-00286
• Device Sequence Number: 1
• Product Code: NRA
• UDI-Device Identifier: 05019279785933
• UDI-Public: (01)05019279785933(17)240207(10)6483393
• 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 Expiration Date: 02/07/2024
• Device Model Number: N/A
• Device Catalogue Number: 159547
• Device Lot Number: 6483393
• 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: 12/11/2022
• 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