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

Catalog Number 72205306

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

Patient Problems Inflammation (1932); Pain (1994)

Event Date 04/15/2021

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference: (b)(4).

Event Description

It was reported that a revision surgery was performed due to something like a chewing gum was found instead of the bioinductive implant 2 months after the first surgery.The patient had pain and the shoulder was inflamed.The bioinductive implant was removed.Patient status is unknown.No further complications reported.

Manufacturer Narrative

The reported device, used in treatment, was not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional testing could not be performed.Arthroscopic images were provided of the surgical site and appeared to show inflamed tissue.Videos were provided but did not have any image or sound.Insufficient product identification information was provided and thus a manufacturing record review could not be conducted.A review of risk management files found that the reported failure was documented appropriately.The instructions for use were reviewed and found to include conditions of off label use and technique specifics, as well as precautions and warnings related to the use of the device.A clinical evaluation was performed based on the provided information.The implant was remove and the patient does not have any pain or inflammation to the shoulder.Since no further harm has been alleged to this patient, no further clinical/medical assessment is warranted at this time.A relationship, if any, between the subject device and the reported event could not be determined.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: BIOINDUCTIVE IMPLANT W ARTHRO DEL MED
• Type of Device: MESH, SURGICAL, COLLAGEN, ORTHOPAEDICS, REINFORCEMENT OF TENDON
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 150 minuteman road; andover MA 01810
• MDR Report Key: 11828620
• MDR Text Key: 250839442
• Report Number: 3003604053-2021-00194
• Device Sequence Number: 1
• Product Code: OWY
• UDI-Device Identifier: 00885556745021
• UDI-Public: 885556745021
• Combination Product (y/n): N
• PMA/PMN Number: K140300
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 10/08/2021

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 72205306
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 04/28/2021
• Initial Date FDA Received: 05/14/2021
• Supplement Dates Manufacturer Received: 10/04/2021
• Supplement Dates FDA Received: 10/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention