MAUDE Adverse Event Report: BIOMET UK LTD. OXF ANAT BRG RT SM SIZE 4 PMA; KNEE PROSTHESIS

Model Number N/A

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Pain (1994)

Event Date 07/27/2023

Event Type  Injury  

Manufacturer Narrative

(b)(4).D10: medical product: oxf twin-peg cmntd fem sm pma; catalog no.: 161468; lot no.: 767490.Medical product: oxf uni tib tray sz aa rm pma; catalog no.: 159532; lot no.: 485700.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2023-00272, 3002806535-2023-00274.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 patient underwent knee prostheses implantation approximately six (6) years ago.About six (6) years later patient complained of knee pain, resulting in revision surgery with exchanging knee prostheses.Attempts have been made and no further information has been provided.

Event Description

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

Manufacturer Narrative

(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2023-00272-1, 3002806535-2023-00274-1.This follow-up report is being submitted to relay additional and/or corrected information.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 that could be related to the reported event.Devices are used for treatment.Radiographs were provided and reviewed by a radiologist.Medial unicompartmental arthroplasty is present.There is radiolucency along the tibial and to a lesser degree femoral implants consistent with osteolysis.There is no implant displacement.There is suspected loosening of the tibial implant but no prior imaging is available for comparison to confirm this.Bone quality is osteopenic.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 ANAT BRG RT SM SIZE 4 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: 17562680
• MDR Text Key: 321309338
• Report Number: 3002806535-2023-00275
• Device Sequence Number: 1
• Product Code: NRA
• UDI-Device Identifier: 05019279786152
• UDI-Public: (01)05019279786152(17)220713(10)006730
• 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: 08/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/17/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/13/2022
• Device Model Number: N/A
• Device Catalogue Number: 159569
• Device Lot Number: 006730
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/06/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/13/2017
• 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): Hospitalization; Required Intervention
• Patient Sex: Female