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

Model Number N/A

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

Patient Problem Insufficient Information (4580)

Event Date 06/03/2023

Event Type  Injury  

Manufacturer Narrative

(b)(4).D10 ¿ associated products: item #unknown femoral component lot #unknown.Item #unknown bearing component lot #unknown.G2 ¿ foreign ¿ poland.H3 - item and lot number unknown.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2023-00214, 3002806535-2023-00215, 3002806535-2023-00216.Investigation of this incident is currently ongoing.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.H3 other text : item and lot number unknown.

Event Description

It was reported that patient underwent revision surgery due to unknown reason.Due diligence is in progress for this complaint; to date, no additional information or product has been received.

Manufacturer Narrative

(b)(4).Upon review of this complaint from an investigation perspective, it is now considered that the unknown tibial component within this complaint was not involved in the reported event regarding the instrument issue.Given the above information, this medwatch will be voided.

Event Description

Upon review of this complaint from an investigation perspective, it is now considered that the unknown tibial component within this complaint was not involved in the reported event regarding the instrument issue.Given the above information, this medwatch will be voided.

• Brand Name: UNKNOWN TIBIAL COMPONENT
• Type of Device: KNEE IMPLANT
• 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: 17246605
• MDR Text Key: 318300264
• Report Number: 3002806535-2023-00215
• Device Sequence Number: 1
• Product Code: NRA
• Combination Product (y/n): N
• Reporter Country Code: PL
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/03/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: UNKNOWN TIBIAL COMPONENT
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/12/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Treatment: SEE H10 NARRATIVE.
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Prefer Not To Disclose