MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ARTHRO BIOINDCTIVE IMPLANT W DEL 1 MED; MESH, SURGICAL, COLLAGEN, ORTHOPAEDICS, REINFORCEMENT OF TENDON

Model Number 4397

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

Patient Problems Pain (1994); Muscle/Tendon Damage (4532)

Event Date 10/28/2021

Event Type  Injury  

Event Description

It was reported that after a partial thickness rotator cuff tear of the articular side procedure with an implant of regeneten, the patient never felt all the way better and the pain increased.The mri showed either new or unhealed partial tear of articular side.Patient was treated with a second surgery, which reveled well integrated regeneten but significant articular sided tear.The surgeon proceeded with takedown and repair.It is unknown the outcome of the patient.

Manufacturer Narrative

Internal complaint reference case: (b)(4).

• Brand Name: ARTHRO BIOINDCTIVE IMPLANT W DEL 1 MED
• 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: 12816541
• MDR Text Key: 281154850
• Report Number: 3003604053-2021-00258
• Device Sequence Number: 1
• Product Code: OWY
• UDI-Device Identifier: 00854501006142
• UDI-Public: 00854501006142
• 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: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2022
• Device Model Number: 4397
• Device Catalogue Number: 4397
• Device Lot Number: A7518
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/28/2021
• Date Device Manufactured: 09/30/2019
• 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