MAUDE Adverse Event Report: BIOMET UK LTD. OXF ANAT BRG LT LG SIZE 4 PMA; UNICONDYLAR KNEE PROSTHESIS

Model Number N/A

Device Problems Use of Device Problem (1670); Appropriate Term/Code Not Available (3191); Noise, Audible (3273)

Patient Problem No Code Available (3191)

Event Date 12/01/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Unique identifier (udi) number: (b)(4).Report source, foreign - event occurred in (b)(6).Customer has indicated that the product is not available for return due to the hospital policy.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that a patient underwent an initial knee arthroplasty on may 20, 2010.Subsequently, a revision procedure due to catching and clicking of the knee was performed on (b)(6) 2020.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.Additional information received: the x-rays (post implant, interim, and pre-revision): unavailable.Surgical reports (primary and revision): received.Hospital name, where the initial surgery took place: (b)(6) hospital.Initial and revision surgeries performed at the same hospital and by same surgeon.Patient information: unavailable on request.The investigation is in process.Once the investigation has been completed, a supplemental mdr will be submitted.

Event Description

It was reported that a patient underwent an initial knee arthroplasty on (b)(6) 2010.Subsequently, a revision procedure due to catching and clicking of the knee was performed on (b)(6) 2020.

Manufacturer Narrative

(b)(4).This final report is being submitted to relay additional information.As the product has not been received, the investigation was limited to the information provided; a review of device history records and complaint history.Information received from the hospital were not surgical notes, but a note from the doctor indicating the size of the cemented component (size d oxf.Cemented component), the closure of wound during the surgery (closed in layers with a single drain), and the use of midline incision to complete the medial compartment uni-knee replacement performed on 20-may-2010.Another two products were reported on the doctor note.However, they will be reported as associated devices, because only the oxf anat brg lt lg size 4 pma has been revised.D11: medical product: oxford partial knee system left medial tibial tray standard size b, catalog #: 154720, lot #: 1748603.Medical product: oxford partial knee system femoral size large, catalog #: 154802, lot #: 1740001.We have not been provided with x-rays or any supporting documentation which could provide additional information.The information received (doctor note) were insufficient to complete an evaluation of the event.A review of the manufacturing history records confirms no abnormalities or deviations reported.Without the opportunity to examine the complaint product and without any supporting documentation, root cause cannot be determined due to insufficient information, furthermore, the supplied photograph does not yield any information that could identify the cause.Risk assessment: risk management report documents the estimated residual risk associated with the reported event.The root cause of the issue could not be determined with the information currently available, therefore the specific failure cause within the risk tables could not be selected for comparison.The reported event states revision due to catching and clicking of the knee.This incident has a maximum severity score of 3 defined in the rmr as moderate prescribed medical or surgical intervention preclude permanent impairment of a body function or body structure.The outcome of the reported event is considered to be within the severity of the rmf.No corrective or preventive actions are deemed necessary at this time.If any additional information becomes available, then the complaint will be reopened and investigated thoroughly.

Event Description

It was reported that a patient underwent an initial knee arthroplasty on (b)(6) 2010.Subsequently, a revision procedure due to catching and clicking of the knee was performed on (b)(6) 2020.Only the oxf anat brg lt lg size 4 pma was revised.

• Brand Name: OXF ANAT BRG LT LG SIZE 4 PMA
• Type of Device: UNICONDYLAR KNEE PROSTHESIS
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• MDR Report Key: 11018101
• MDR Text Key: 221706788
• Report Number: 3002806535-2020-00538
• Device Sequence Number: 1
• Product Code: NRA
• Combination Product (y/n): N
• PMA/PMN Number: P010014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 01/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2014
• Device Model Number: N/A
• Device Catalogue Number: 159555
• Device Lot Number: 1725836
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 78 YR