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); Synovitis (2094); Arthralgia (2355); Tissue Breakdown (2681)

Event Date 03/30/2022

Event Type  Injury  

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 49 years old female was treated arthroscopically 2 months post-injury for a partial-thickness rotator cuff tear on his right shoulder using a bioinductive collagen scaffold.The patient recovered well until five months postoperatively when she injured her right shoulder while lifting her fallen mother from the floor.The mri showed exuberant subacromial bursitis with diffuse synovial proliferation.Given the amount of subacromial fluid and concern for infection, an aspiration was performed that was negative for an infectious process after holding anaerobic cultures for 3 weeks.On re-evaluation three months later, her pain persisted, unrelieved by medical management, aspiration, and corticosteroid injection.A third mri was performed that demonstrated progressive improvement of the posterosuperior rotator cuff tendons with further decreased heterogeneity suggestive of continued healing.The patient underwent arthroscopic revision surgery, which showed abundant subacromial bursitis, adhesions, and fraying of the coracoacromial ligament.The subacromial space was debrided of adhesions.A subacromial decompression was performed.The histologic demonstrated complete integration of the graft with native tissue.On the initial two-week postoperative visit, the patient was recovering well with no reports of residual pain or loss of function.Her symptoms of bursitis, swelling, and pain at rest were resolved.

Manufacturer Narrative

Internal complaint reference: case (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.

• 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: 16675375
• MDR Text Key: 312628598
• Report Number: 3003604053-2023-00012
• 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: Foreign,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
• 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: 49 YR
• Patient Sex: Female