MAUDE Adverse Event Report: SMITH & NEPHEW, INC. UNKN REGENETEN BIOINDUCTIVE IMPLANT SYSTEM IMPL; MESH, SURGICAL, COLLAGEN, ORTHOPAEDICS, REINFORCEMENT OF TENDON

Catalog Number UNKNOWN

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

Patient Problems Granuloma (1876); Rupture (2208)

Event Date 08/30/2021

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference (b)(4).

Event Description

It was reported that a revision surgery was performed on a patient were previously a regeneten implant was used.A granuloma cyst and a large bone void were identified at the procedure.Cultures were taken.Current status of the patient and how the issue was resolved is unknown.

Manufacturer Narrative

Additional information: health effect - clinical and impact code.The reported device was not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional testing could not be performed.Insufficient product identification information was provided and thus a manufacturing record review, complaint history review, risk management review, and an instructions for use/device labeling review could not be conducted.Based on the information available, there were no indications to suggest that the product did not meet manufacturing specification upon release for distribution.A clinical review states that smith and nephew has not received the device nor adequate clinical documentation to fully evaluate the complaint.The impact to the patient beyond that which has already been reported, cannot be determined.Should any additional relevant medical information be provided, this complaint would be re-assessed.There was no relationship found between the device and the reported event.The complaint was not confirmed please refer to the instructions for use for recommendations on proper use of the device and potential troubleshooting methods to prevent future reoccurrence of the reported event.No containment or corrective actions are recommended at this time.If the product associated with this event is returned at a future date, this investigation will be reopened for evaluation.

• Brand Name: UNKN REGENETEN BIOINDUCTIVE IMPLANT SYSTEM IMPL
• Type of Device: MESH, SURGICAL, COLLAGEN, ORTHOPAEDICS, REINFORCEMENT OF TENDON
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 150 minuteman road; andover MA 01810
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 150 minuteman road; andover MA 01810
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 12531225
• MDR Text Key: 273292867
• Report Number: 3003604053-2021-00249
• Device Sequence Number: 1
• Product Code: OWY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K140300
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 02/10/2023

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/01/2021
• Initial Date FDA Received: 09/27/2021
• Supplement Dates Manufacturer Received: 12/06/2022; 02/10/2023
• Supplement Dates FDA Received: 12/08/2022; 02/10/2023
• 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
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Female