MAUDE Adverse Event Report: BIOMET UK LTD. OXF ANAT BRG LT LG SIZE 3 PMA; KNEE PROSTHESIS

Model Number N/A

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Failure of Implant (1924); Pain (1994); Ambulation Difficulties (2544); Swelling/ Edema (4577)

Event Type  Injury  

Event Description

The patient underwent an initial left knee hemiarthroplasty.Subsequently, the patient experienced loosening, swelling, and difficulty ambulating.No revision procedure has occurred at this time.Due diligence is in progress for this complaint; to date, no additional information or product has been received.

Manufacturer Narrative

Cmp-(b)(4).Concomitant medical products: item#: 161470; lot#: unknown; item#: 154724; lot#: unknown.Therapy date: unknown.Investigation of this incident is currently ongoing.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.Multiple mdr reports were filed for this event, please see the associated reports: 3002806535 -2022 -00420; 3002806535 -2022 -00421.

Manufacturer Narrative

Cmp-(b)(4).This follow-up report is being submitted to relay additional information.Part and lot identification are necessary for review of device history records, neither were provided.Medical records and radiographs were provided and reviewed by a healthcare professional.Review of the available records identified the following: interval postsurgical changes compatible with a hemiarthroplasty of the medial compartment of the left knee, mild osteoarthritic change of the lateral and patellofemoral compartments, enthesophyte noted along the quadriceps tendon insertion site upon the patella, tiny suprapatellar joint effusion is suspected.Contributing factor of the event is obesity a definitive root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental 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

(b)(4).D10: item#: 154724; lot#: 955030.Item#: 161470; lot#: 674580.This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, d4, d10, g3, g6, h4, h6, h10.This complaint was re-opened due to further medical notes becoming available which also includes lot numbers being established.A review of the device manufacturing records confirmed no abnormalities or deviations that could be related to the reported event.Medical notes being received and these were reviewed by a health care professional who reported that initial xray: chronic pain, x-ray: possible hardware loosening, discussed possible revision, pain meds provided.Second x-ray: no fracture, effusion, swelling, or calcifications; unchanged degree of lucency in the medial femoral condyle and medial tibial plateau.Third x-ray: demineralization of the bones, components in similar alignment as compared to previous xrays, degenerative changes to patellofemoral compartment, no fracture, small joint effusion, mild soft tissue swelling, lucency at the bone cement interface.The root cause of the reported issue is remains to be attributed to patient condition being disease progression.

Event Description

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

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.This complaint was re-opened due to medical notes being received and these were reviewed by a health care professional who reported that the revision occurred due to severe arthritic changes in the knee.The partial knee components were found to be well-fixed during the revision.A competitor total knee was placed without complications.The root cause of the reported issue is attributed to patient condition being disease progression.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

It was reported that the patient underwent revision surgery due to loosening, swelling, difficulty ambulating, and severe arthritic changes in the knee.

• Brand Name: OXF ANAT BRG LT LG SIZE 3 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: 15560367
• MDR Text Key: 301336951
• Report Number: 3002806535-2022-00422
• Device Sequence Number: 1
• Product Code: NRA
• 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: Other,Consumer
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 12/07/2023

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 Expiration Date: 07/25/2022
• Device Model Number: N/A
• Device Catalogue Number: 159554
• Device Lot Number: 313150
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/09/2022
• Initial Date FDA Received: 10/07/2022
• Supplement Dates Manufacturer Received: 11/02/2022; 10/06/2023; 11/09/2023
• Supplement Dates FDA Received: 11/29/2022; 11/02/2023; 12/07/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/25/2017
• 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
• Patient Outcome(s): Hospitalization; Required Intervention; Other
• Patient Sex: Male
• Patient Weight: 136 KG