MAUDE Adverse Event Report: BIOMET UK LTD. OXFORD PH3 CEMENTLESS FEM SZ M; PROSTHESIS, KNEE, FEMOROTIBIAL, UNICOMPARTMENTAL

Model Number N/A

Device Problem Malposition of Device (2616)

Patient Problem Pain (1994)

Event Date 02/22/2024

Event Type  Injury  

Manufacturer Narrative

(b)(4).D-10 oxf uni cmntls tib sz c rm, item# 166575, lot# 7246480.Oxf anat brg rt md size 6 pma, item# 159578, lot# 7052368.G2 ¿ foreign ¿ netherlands.Multiple mdr reports were filed for this event, please see associated reports: 3002806535 - 2024 - 00093, 3002806535 - 2024 - 00094.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 from a clinical study that a patient had an initial right medial knee unicondylar arthroplasty approximately one year ago.A month ago the patient was converted to a total knee arthroplasty due to persistent pain and malalignment.Due diligence is in progress for this complaint; to date no additional information or product has been received.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the complaint histories identified additional similar complaints for the item ref.166575, no additional related complaints for items ref.154926 and 159578, and no additional similar complaints for the reported part and lot combinations.Medical records were provided and reviewed by a health care professional.The review of the initial notes identified an uncemented initial medial knee hemiarthroplasty without complications.Review of the revision notes identified a revision due to malalignment and persistent pain, without complication.No contributing factors to the event were found.Radiographs were provided and reviewed by a radiologist.The review of the immediate post-op images demonstrates anatomic alignment of a medial unicompartmental arthroplasty without abnormality.An interval change in position of the tibial implant which appears slightly rotated and subsided was identified.A lateral view would be of value for better characterization of the implant position.There is no fracture.Finally, a review of the x-ray in the standing position, revealed the tibial implant appearing again malpositioned but unchanged.There is pelvic obliquity higher on the left.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 M
• Type of Device: PROSTHESIS, KNEE, FEMOROTIBIAL, UNICOMPARTMENTAL
• 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: 18920187
• MDR Text Key: 337847343
• Report Number: 3002806535-2024-00092
• Device Sequence Number: 1
• Product Code: NRA
• UDI-Device Identifier: 00887868353772
• UDI-Public: (01)00887868353772(17)321031(10)7349086
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: P010014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/18/2024

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?: No
• Device Operator: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: 154926
• Device Lot Number: 7349086
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/23/2024
• Initial Date FDA Received: 03/18/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/31/2022
• 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
• Treatment: SEE H10 NARRATIVE
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Sex: Male
• Patient Weight: 105 KG