MAUDE Adverse Event Report: BIOMET UK LTD. OXF UNI TIB TRAY SZ D LM PMA; KNEE PROSTHESIS

Model Number N/A

Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problems Cyst(s) (1800); Bone Fracture(s) (1870); Pain (1994)

Event Date 09/21/2023

Event Type  Injury  

Manufacturer Narrative

(b)(4).D10: oxf twin-peg cmntd fem lg pma; ref#161470; lot#056160.Oxf anat brg lt lg size 5 pma; ref#159556; lot#2944765.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 approximately 9 years and 5 months post-implantation, the patient underwent revision surgery from a partial knee to a total knee due to pain, aseptic loosening, tibial bone collapse, and a cyst forming.Due diligence is in progress for this complaint; to date no additional information or product has been received.

Event Description

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

Manufacturer Narrative

(b)(4).No product was returned or pictures provided; visual and dimensional evaluations could not be performed.A review of the device manufacturing records confirmed no abnormalities or deviations.The device is used for treatment.Radiographs were provided and reviewed by a radiologist.There is a medial unicompartmental arthroplasty with a medially subsided and loose tibial implant.Radiolucency is present at the central tibial plateau.There is mild knee varus.Loosening and subsidence of the tibial implant of the medial unicompartmental arthroplasty.With the available information, a definitive root cause cannot 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.

• Brand Name: OXF UNI TIB TRAY SZ D LM PMA
• Type of Device: KNEE PROSTHESIS
• 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: 17938000
• MDR Text Key: 325676791
• Report Number: 3002806535-2023-00350
• Device Sequence Number: 1
• Product Code: NRA
• UDI-Device Identifier: 05019279388905
• UDI-Public: (01)05019279388905(17)240203(10)945640
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P010014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/16/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/03/2024
• Device Model Number: N/A
• Device Catalogue Number: 154724
• Device Lot Number: 945640
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/25/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/03/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: SEE H10 NARRATIVE
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Sex: Male