MAUDE Adverse Event Report: BIOMET UK LTD. OXFORD ANAT BRG LT SM SIZE 5 PMA; KNEE PROSTHESIS

Model Number N/A

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

Patient Problems Pain (1994); Loss of Range of Motion (2032); Swelling/ Edema (4577)

Event Type  Injury  

Manufacturer Narrative

(b)(4).D10 ¿ unknown oxford femoral component, item# unknown, lot# unknown.Unknown oxford tibial baseplate, item# unknown, lot# unknown.Unknown palacos cement, item# unknown, lot# unknown.H3 ¿ other: device evaluation could not be performed as part# and lot# are unknown.Multiple mdr reports were filed for this event, please see associated reports: 3002806535 - 2024 - 00002, 3002806535 - 2024 - 00003.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 a patient had an initial left unicompartmental knee arthroplasty approximately a year and a half ago.Subsequently, the patient had a slow progressive recovery and never experienced pain relief.The reported pain was initially in the posterior lateral knee along with swelling, stiffness, and limited flexion and radiographic imaging pointed towards lateral degenerative changes.The patient was noted to have hypersensitivity and was diagnosed with chronic knee pain and fibromyalgia.Radiographic imaging taken post operatively displayed a round area of periprosthetic lucency with thin sclerotic margins at the cement bone interface of the posterior femoral post, a lucency beneath the cement bone interface posteriorly on the tibial component, and the femoral component was noted to be somewhat posterior with a slight lateral patellar tilt.The surgeon has discussed a possible revision and is seeking specialty care for an approach to prevent complex regional pain syndrome from developing if another surgery is required.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

This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, d1, d4, e1, e4, g2, g3, g6, h1, h2, h3, h4, h6, h10.D10 ¿ oxf twin-peg cmntd fem sm pma, item# (b)(4), lot# 687840 oxf uni tib tray sza lm, item# (b)(4), lot# 407710 palacos cement, item# (b)(4), lot# 91414840 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.

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.A review of the device manufacturing records confirmed no abnormalities or deviations that could be related to the reported event.Reported event was confirmed by review of medical records and x-rays by a health care professional.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

It was reported a patient had an initial left unicompartmental knee arthroplasty approximately nineteen months ago.Subsequently, had a slow progressive recovery and never experienced pain relief.The reported pain was initially in the posterior lateral knee along with swelling, stiffness, and limited flexion and radiographic imaging pointed towards lateral degenerative changes.The patient was noted to have hypersensitivity and was diagnosed with chronic knee pain and fibromyalgia.The patient reported the knee giving out with persistent pain.Later radiographic imaging displayed a round area of periprosthetic lucency with thin sclerotic margins at the cement bone interface of the posterior femoral post, lucency beneath the cement bone interface posteriorly on the tibial component, and the femoral component was noted to be somewhat posterior with a slight lateral patellar tilt.The surgeon has discussed a possible revision and is seeking specialty care for an approach to prevent complex regional pain syndrome from developing if another surgery is required.Approximately a month ago, the patient had a consult for a second opinion.Radiographic imaging was completed that displayed the tibial component in somewhat varus alignment and a moderate effusion.A discussion was conducted regarding a conversion to a total knee arthroplasty and the patient agreed to proceed with scheduling.Attempts have been made and no further information has been provided.

Manufacturer Narrative

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: OXFORD ANAT BRG LT SM SIZE 5 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: 18424303
• MDR Text Key: 331779432
• Report Number: 3002806535-2024-00001
• Device Sequence Number: 1
• Product Code: NRA
• UDI-Device Identifier: 05019279785889
• UDI-Public: (01)05019279785889(17)240407(10)658010
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 04/24/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/02/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/07/2024
• Device Model Number: N/A
• Device Catalogue Number: 159542
• Device Lot Number: 658010
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/18/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/07/2019
• 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): Other
• Patient Sex: Female
• Patient Weight: 65 KG