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

Catalog Number	4566
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Synovitis (2094); Muscle/Tendon Damage (4532); Swelling/ Edema (4577); Bursitis (4832)
Date of Event	08/13/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that after an arthroscopy, the doctor was worried that the regeneten implant caused side effects.The patient presented to the clinic with discomfort swelling and shoulder pain.A multiplanar multisequence mri without contrast was made on the right shoulder.The results showed that there was large amount of fluid in the sub acromial subdeltoid bursa, complex fluid with internal areas of linear synovial thickening.The complex fluid extends through a defect or widening across the acromioclavicular joint into the adjacent soft tissues of the cranial margin or the acromioclavicular joint with a large fluid collection with nodular thickened areas.This may represent complex subacromial subdeltoid bursitis which was decompressed into the acromial clavicular joint with decompression into the cranial soft tissues across the acromioclavicular joint.Supraspinatus tendinosis with acute partial thickness partial width low grade articular surface tear without the tendon retraction muscle atrophy.Infraspinatus tendinosis with acute partial thickness partial width low grade articular surface/insertional tear without tendon retraction muscle atrophy or edema.It is unknow how it was treated and what was the patient outcome.
Additional Manufacturer Narrative
H10: internal complaint reference: (b)(4).H6: this complaint was opened by smith+nephew to document a patient complication reported that includes reference to the use of a smith+nephew product without evidence about a specific product problem.The reported complication relates to known inherent procedural risks that are appropriately documented in our risk files.Smith+nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.Smith+nephew has no reason to suspect that the product failed to meet any specifications at the time of manufacture.Based on our review of all currently available information, we are unable to confirm a relationship between the reported event and the device or identify a definitive root cause.However, as the use of our product cannot be excluded as a potential cause or contributory factor to the reported issue, we are submitting this report in accordance with applicable regulations.If additional investigative findings or information becomes available that alters the conclusions of this report, a follow-up report will be submitted as required.

• Brand Name: BIOINDUCTIVE IMPLANT W/ARTH DEL LRG
• Common Device Name: 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: 20875398
• Report Number: 3003604053-2024-00068
• Device Sequence Number: 18093966
• Product Code: OWY
• UDI-Device Identifier: 00885556735664
• UDI-Public: 885556735664
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K140300
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/08/2024

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
• Operator of Device: Health Professional
• Device Catalogue Number: 4566
• Device Lot Number: 2139573
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/20/2024
• Initial Report FDA Received Date: 12/08/2024
• Date Device Manufactured: 12/06/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown