MAUDE Adverse Event Report: BIOMET UK LTD. UNKNOWN TINBN TIBIAL COMPONENT; KNEE ARTHROPLASTY

Model Number N/A

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

Patient Problems Pain (1994); Ambulation Difficulties (2544)

Event Date 06/16/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).Initial report.Report source, foreign - event occurred in (b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as it remains implanted.Multiple mdr reports were filed for this event, please see associated report: 3002806535-2021-00302.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

Initial right tka on (b)(6) 2011.At ten year follow up, patient reported severe pain that interferes with activities of daily living.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.Additional information received: healthcare facility: (b)(6).Multiple mdr reports were filed for this event, please see associated report: 3002806535-2021-00302-1.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

Initial right tka on (b)(6) 2011.At ten year follow up, patient reported severe pain that interferes with activities of daily living.

Manufacturer Narrative

(b)(4) this follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, d4, g3, g6, h1, h2, h10 additional information received: product numbers of the components.Description: tinbn coated vanguard cr interlok femoral component 62.5mm right item: 183006tnbn description: polished finned 1 piece tibial tray 71mm coat.Tinbn item: 141253tnbn patella was not resurfaced, articular surface unknown x-rays and surgical reports? requested.Whether revision surgery is planned? information requested.Patient details: name - not permitted.Date of birth ¿ 1960.Activity level - mostly inactive: very restricted to minimum activities of daily living weight ¿ unknown.Does the available information suggest the device/product caused or contributed to a death or serious injury? no, the surgeon chose not to report an adverse event so no serious injury took place.Was there medical intervention? no medical intervention was reported as no death or serious injury occurred.Preop, the patient presented with previous high valgus tibial repositioning osteotomy (hto), failed cruciate ligament arthroplasty and multiple knee arthroscopies.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

Initial right tka on (b)(6) 2011.At ten year follow up, patient reported severe pain that interferes with activities of daily living.

Manufacturer Narrative

(b)(4).Product has been identified as valencia design control.Upon reassessment it was determined an mdr should not have been filed under the current manufacturer.This product will be reported by medwatch facility biomet spain - (b)(4).

Event Description

Initial right tka on (b)(6) 2011.At ten year follow up, patient reported severe pain that interferes with activities of daily living.

• Brand Name: UNKNOWN TINBN TIBIAL COMPONENT
• Type of Device: KNEE ARTHROPLASTY
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• MDR Report Key: 12141671
• MDR Text Key: 260679639
• Report Number: 3002806535-2021-00303
• Device Sequence Number: 1
• Product Code: HSX
• 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,Followup,Followup
• Report Date: 09/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/09/2021
• 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: 141253TNBN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 61 YR