MAUDE Adverse Event Report: . UNK OXFORD FEMORAL COMPONENT; KNEE PROSTHESIS

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problems Pain (1994); Seroma (2069)

Event Date 08/14/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Customer has indicated that the product is in the process of being returned to zimmer biomet for investigation.Once the investigation is complete, a supplemental mdr will be submitted.Concomitant medical products: medical product: unk oxford tibial tray catalog #: not reported lot #: not reported , medical product: unk oxford bearing catalog #: not reported lot #: not reported.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2019-00909, 3002806535-2019-00911.The investigation is in process.Once the investigation is complete, a follow-up mdr will be submitted.

Event Description

It was reported patient underwent a left tka.Subsequently, patient was revised due to seroma and pain.The procedure included irrigation and débridement of left knee with polyethylene component exchange.

Event Description

It was reported patient underwent a left tka.Subsequently, patient was revised due to seroma and pain.The procedure included irrigation and deridement of left knee with polyethylene component exchange.

Manufacturer Narrative

(b)(4).D10: attempts were made to obtain additional information.However, none was available.D11: medical product: unknown oxford tibial tray, catalog #: unknown, lot #: unknown.Medical product: unknown oxford bearing, catalog #: unknown, lot #: unknown.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2019-00909-1, 3002806535-2019-00911-1.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 could not be performed as it is unavailable.A review of the complaint database could not be performed as item number is unavailable.Without the opportunity to examine the complaint product, the root cause cannot be determined due to insufficient information.Risk assessment: without the opportunity to examine the complaint product and without adequate information received regarding the event, the root cause could not be determined and therefore risk could not be assessed against occurrence or any new previously unidentified risk.Corrective action taken: no corrective action required at this time.Preventive action taken: no preventive action required at this time if any additional information becomes available, then the complaint will be reopened and investigated thoroughly.H3 other text : product has not been returned.

Manufacturer Narrative

(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2019-00909-2, 3002806535-2019-00911-2.Upon reassessment of the reported event, it was determined an mdr should not have been filed under the current manufacturer.This event will be reported by medwatch facility warsaw biomet ¿ (b)(4).

Event Description

It was reported patient underwent a left total knee arthroplasty.Subsequently, patient was revised due to seroma and pain.The procedure included irrigation and deridement of left knee with polyethylene component exchange.

• Brand Name: UNK OXFORD FEMORAL COMPONENT
• Type of Device: KNEE PROSTHESIS
• Manufacturer (Section D): .; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• MDR Report Key: 9415504
• MDR Text Key: 169213307
• Report Number: 3002806535-2019-00910
• 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: consumer,health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 09/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2019
• 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: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 45 YR
• Patient Weight: 154