MAUDE Adverse Event Report: BIOMET UK LTD. OXFORD UNI TIB TRAY 44X28 RLLM; UNICONDYLAR KNEE PROSTHESIS

Model Number N/A

Device Problems Fracture (1260); Material Integrity Problem (2978); Insufficient Information (3190); Appropriate Term/Code Not Available (3191)

Patient Problems Edema (1820); Pain (1994); Swelling (2091)

Event Date 09/05/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Initial report: the product remains implanted in the patient.Once the investigation has been completed, a supplemental mdr will be submitted.Medical product: item name # unknown oxford femoral component, catalog #: unknown lot #: unknown.Medical product: item name # unknown oxford bearing, catalog #: unknown lot #: unknown.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2020-00405, 3002806535-2020-00407.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Devices remain implanted.

Event Description

It was reported that patient underwent partial knee arthroplasty on an unknown date.Subsequently, patient moved and immediately experienced pain and swelling.Patient lives in remote place and is looking for surgeon to look at his knee.

Manufacturer Narrative

(b)(4).Concomitant medical products: medical product: 154602, catalog #: oxford uni femoral lg, lot #: 1240431 medical product: 154634, catalog #: oxford uni tib brg lg sz3, lot #: 1140466 medical product: 418000, catalog #: optivac total hip kit, lot #: 650600 multiple mdr reports were filed for this event, please see associated reports: 3002806535-2020-00405-1, 3002806535-2020-00407-1.The investigation is in process.Once the investigation has been completed, a supplemental mdr will be submitted.

Event Description

It was reported that patient underwent partial knee arthroplasty on (b)(6) 2007.Subsequently, patient moved and immediately experienced pain and swelling.It was reported that a revision surgery was performed due to pain, swelling and instability caused by the bearing fracture on (b)(6) 2020.

Event Description

It was reported that patient underwent partial knee arthroplasty on an (b)(6) 2007.Subsequently, the patient moved and immediately experienced pain and swelling.It was reported that a revision surgery was performed due to pain, swelling and instability caused by the bearing fracture on (b)(6) 2020.

Manufacturer Narrative

(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2020-00405- 2, 3002806535-2020-00407- 2.As the product has not been received, the investigation was limited to the information provided; a review of device history records and complaint history.We have not been provided with x-rays or any supporting documentation which could provide additional information.A review of the manufacturing history records confirms no abnormalities or deviations reported.A review of the complaint database over the last 3 years has found no similar complaints reported with the item and lot combination.A review of the complaint database over the last 3 years has found 1 similar complaints reported with the item 154602 and item 154634, and no similar complaints reported with the item 154609.Without the opportunity to examine the complaint product, root cause cannot be determined due to insufficient information.Risk assessment: the event reports revision due to pain, swelling and instability caused by the bearing fracture.Risk management report documents the estimated residual risk associated with the device within the reported event.The root cause of the issue however 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 pain.In the risk file, this has a maximum severity score of 4 defined in the rmp as results in permanent impairment of body function or permanent damage to a body structure / necessitates surgical intervention.The reported event also states swelling.In the risk file, inflammation of soft tissues is considered harm (effect on patient) with a maximum severity level of 4 for a number of hazards defined as results in permanent impairment of body function or permanent damage to a body structure / necessitates surgical intervention.The reported event also states instability.In the risk file, this has a maximum severity score of 4 defined in the rmp as results in permanent impairment of body function or permanent damage to a body structure / necessitates surgical intervention.The reported event also states revision due to fracture insert.This has a severity score of 4 defined in the rmr as results in permanent impairment of body function or permanent damage to a body structure / necessitates surgical intervention.The outcome of the reported event (surgical intervention) 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.

• Brand Name: OXFORD UNI TIB TRAY 44X28 RLLM
• Type of Device: UNICONDYLAR KNEE PROSTHESIS
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• MDR Report Key: 10493485
• MDR Text Key: 205657294
• Report Number: 3002806535-2020-00406
• 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,consum
• Type of Report: Initial,Followup,Followup
• Report Date: 01/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/04/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2016
• Device Model Number: N/A
• Device Catalogue Number: 154609
• Device Lot Number: 1147484
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention
• Patient Age: 78 YR
• Patient Weight: 84