MAUDE Adverse Event Report: OXF ANAT BRG RT SM SIZE 6 PMA; OXFORD HXLPE BEARINGS

Model Number N/A

Device Problem Fracture (1260)

Patient Problem Failure of Implant (1924)

Event Date 01/19/2024

Event Type  Injury  

Manufacturer Narrative

(b)(4).D10 - medical devices: oxf uni tib tray sz b rm pma; item# 154721; lot# 3141543.Oxford uni twin-peg femoral sm; item# 166941; item# 3221835.Optipac 40 refobacin bone cement r; item# 4710500394; lot# a3238e1308.G2 - foreing: germany.Investigation of this incident is currently ongoing.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.

Event Description

It was reported that a patient had an initial bilateral knee medial unicondylar arthroplasty performed.Subsequently, the patient underwent revision of the right knee due to fracture of the bearing.Due diligence is in progress for this complaint; to date no additional information or product has been received.

• Brand Name: OXF ANAT BRG RT SM SIZE 6 PMA
• Type of Device: OXFORD HXLPE BEARINGS
• MDR Report Key: 18719353
• MDR Text Key: 335522627
• Report Number: 3002806535-2024-00060
• 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: Foreign,Health Professional,Company Representative
• Type of Report: Initial
• Report Date: 02/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/31/2014
• Device Model Number: N/A
• Device Catalogue Number: 159571
• Device Lot Number: 1859334
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/24/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/09/2009
• 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): Hospitalization; Required Intervention
• Patient Age: 70 YR
• Patient Sex: Female