MAUDE Adverse Event Report: BIOMET UK LTD. TINBN VG INT PS ANAT FM L 60MM; METAL SENSITIVE VGD PS FMRL

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Loss of Range of Motion (2032); Scar Tissue (2060)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Initial report.Report source, foreign - event occurred in europe: (b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as it remains implanted.Associated products: medical product: e1 vngd ps tib brg 63/67x14, catalog no.: ep-183624, lot no.: unknown.Medical product: polished finned tib tray 67mm, catalog no.: 141252tnbn, lot no.: unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Device remains implanted.

Event Description

(b)(6).It was reported that a left total knee arthroplasty performed on an unknown date in 2013.Subsequently, the patient underwent an arthrolysis due to range of motion issues.Range of motion continued to be a problem after the arthrolysis, and the patient had a maquet osteotomy and patella baja.No product has been exchanged.

Manufacturer Narrative

(b)(4).This final report is being submitted to relay additional information.Complaint summary: as the product has not been received, the investigation was limited to the information provided; a review of complaint history.In addition, we have not been provided with any supporting documentation which could provide additional information.Mhr review could not be performed as lot number is unknown.A review of the complaint database over the last 3 years has found no similar complaints reported with the item.Without the opportunity to examine the complaint product, root cause cannot be determined due to insufficient information.If any additional information becomes available, then the complaint will be reopened and investigated thoroughly.Capa: no corrective or preventive action required at this time.If any further information is found which would change or alter any conclusions or information, a supplemental will be submitted accordingly.Zimmer biomet will continue to monitor for trends.H3 other text : device remains implanted.

Event Description

Clinical study: vanguard ps tinbn pmcf, study site: belgium.It was reported that a left total knee arthroplasty performed on an unknown date in 2013.Subsequently, the patient underwent an arthrolysis due to range of motion issues.Range of motion continued to be a problem after the arthrolysis, and the patient had a maquet osteotomy and patella baja.No product has been exchanged.

• Brand Name: TINBN VG INT PS ANAT FM L 60MM
• Type of Device: METAL SENSITIVE VGD PS FMRL
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• MDR Report Key: 12230652
• MDR Text Key: 268063502
• Report Number: 3002806535-2021-00325
• Device Sequence Number: 1
• Product Code: HRY
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,study
• Type of Report: Initial,Followup
• Report Date: 08/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 183124TNBN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEEH10.
• Patient Outcome(s): Hospitalization; Other
• Patient Weight: 80