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

Catalog Number UNKNOWN

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

Patient Problems Adhesion(s) (1695); Inflammation (1932); Scar Tissue (2060); Synovitis (2094); Arthralgia (2355)

Event Date 03/30/2022

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference: (b)(4).Wietlisbach, l.E., cheema, a.N., huang, j.H., luo, x., & huffman, g.R.(2022).Revision arthroscopic surgery after rotator cuff repair with a collagen graft: histologic evaluation of biopsy specimens from two patients.Jses reviews, reports & techniques, 2(3), 412-418.Doi: doi.Org/10.1016/j.Xrrt.2022.02.008 this complaint was opened by smith+nephew to document a patient complication identified through a review of clinical evidence from literature sources that includes reference to the use of a smith+nephew product.The reported issue(s) relate 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 conservatively submitting this report in accordance with applicable regulations.If additional information becomes available that alters the conclusions of this report, a follow-up report will be submitted as required.

Event Description

It was reported that in the literature review "revision arthroscopic surgery after rotator cuff repair with a collagen graft: histologic evaluation of biopsy specimens from two patients"; a 74 years old male was treated arthroscopically 4 months post-injury for a full-thickness rotator cuff tear on his left shoulder.During the operation, a bioinductive collagen scaffold was placed and secured with four poly l-lactide (plla) sutures and two lateral bone (peek) staples.First two months post-op with minimal reports of pain and improved functionality.Three months postop the patient reported an acute atraumatic increase in pain not relieved with conservative management.The mri revealed improved tendon thickness and decreased signal at the tear, but there was subacromial and subdeltoid fluid consistent with reactive bursitis.The patient underwent debridement, and revision surgery, it was noted that the deep layer of the scaffold was well integrated, but the superficial layer of the scaffold had delaminated and flipped into the subdeltoid recess.The loose scaffold material was removed, along with the peek staples and plla sutures.The histologic assessment resulted in no growth without evidence of an infector or foreign body inflammatory reaction.The patient was recovering well and had an uneventful follow-up.

• Brand Name: UNKNOWN REGENETEN BIOINDUCTIVE IMPLANT SYSTEM INSTR
• 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: 16675311
• MDR Text Key: 312623629
• Report Number: 3003604053-2023-00011
• Device Sequence Number: 1
• Product Code: OWY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2023
• 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
• Date Manufacturer Received: 03/16/2023
• 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 Age: 74 YR
• Patient Sex: Male