MAUDE Adverse Event Report: BIOMET UK LTD. OXFORD PH3 CEMENTLESS FEM SZ L; OXFORD CEMENTLESS FEMORALS

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Pain (1994)

Event Date 10/04/2023

Event Type  Injury  

Manufacturer Narrative

(b)(4).D10 ¿ medical devices: oxf anat brg rt lg size 3 pma; item# 159582; lot# 7316681.Oxf uni cmntls tib sz d rm; item# 166577; lot# 7331854.G2 ¿ foreign: australia.Multiple mdr reports were filed for this event, please see associated reports: 3002806535 - 2023 - 00362 and 3002806535 - 2023 - 00363.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.

Event Description

It was reported that the patient underwent a uni knee arthroplasty and approximately 4 months later a revision surgery was performed due to disease progression and pain.Attempts have been made and no further information has been provided.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.Visual examination of the provided pictures identified that the femoral implant has bone ingrowth on the porous posterior facet with signs of cortical bone present, the tibial implant has bone ingrowth on the porous distal face with less towards the posterior edge.No further information can be gleaned from the provided pictures.A review of the device manufacturing records confirmed no abnormalities or deviations that could be related to the reported event.Devices are used for treatment.Radiographs were provided and reviewed by a radiologist.The review identified a medial unicompartmental arthroplasty is present.There is radiolucency along the posterior flange of the femoral implant which appears posteriorly positioned and not fully seated against the posterior medial femoral condyle.The tibial implant is also posteriorly positioned in relation to the tibial plateau.There is no fracture.Radiolucency along the posterior flange of the right knee medial unicompartmental arthroplasty with posterior position of the femoral and tibial implants as noted.With the available information, a definitive root cause could not be determined.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

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

• Brand Name: OXFORD PH3 CEMENTLESS FEM SZ L
• Type of Device: OXFORD CEMENTLESS FEMORALS
• 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: 18053223
• MDR Text Key: 327127599
• Report Number: 3002806535-2023-00361
• Device Sequence Number: 1
• Product Code: NRA
• UDI-Device Identifier: 00887868353789
• UDI-Public: (01)00887868353789(17)321218(10)7371581
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/09/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: 154927
• Device Lot Number: 7371581
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/04/2023
• Initial Date FDA Received: 11/02/2023
• Supplement Dates Manufacturer Received: 01/05/2024
• Supplement Dates FDA Received: 01/09/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/23/2022
• 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
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Sex: Female