MAUDE Adverse Event Report: SMITH & NEPHEW, INC. REGENETEN PATCH; MESH, SURGICAL, COLLAGEN, ORTHOPAEDICS, REINFORCEMENT OF TENDON

Catalog Number UNKNOWN

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Fatigue (1849); Fever (1858); Failure of Implant (1924); Injury (2348); Implant Pain (4561)

Event Date 02/10/2020

Event Type  Injury  

Event Description

It was reported that a shoulder surgery was performed, (b)(6) 2019, for a biceps tendon rupture using a regeneten patch.While doing physical therapy, (b)(6) 2020, the patient began experiencing pain in wrists, fingers, knee, elbows, feet, toes and ankles.Additionally, the patient also experienced severe fatigue, fever and pain.Physician follow-up, (b)(6) 2020, found shoulder tenderness, no swelling and suspects patient might suffer from arthritis.Physician prescribed prednisone.Patient's outcome is unknown.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

H2, h6.Lot number information is not provided and no additional information was received for documentation review.If additional information is received, the documentation review will be revisited.With the provided information, smith and nephew is unable to determine if device met manufacturing specifications.Several complaints related to pain post procedure with scaffold have been observed.The risks associated with this complaint are already included in the risk analysis.Also, the frequency is appropriate.Instructions for use and product labels were not reviewed due to unavailability of device information (part number, lot number).The product used for treatment, was not returned for evaluation, and therefore a physical investigation could not be completed.Based on the information provided the acute pain experienced by the patient was likely due to the re-tear of the repaired supraspinatus.The root cause of the fatigue, fever and pain could not be determined with the information provided, however the patient¿s medical history is significant for comorbidities which cannot be ruled out as possible contributing factors.Per the patient¿s medical record the physician stated that it ¿is unlikely that there is a foreign body reaction from graft.Pain likely caused by new exercised by the new therapist,¿ and not a mal performance of the s&n devices.The patient impact beyond the reported issues cannot be concluded.No further medical assessment is possible at this time based on the information provided.In conclusion, there is insufficient information to determine a root cause.A probable cause of the failure mode experienced by the user facility was unable to be confirmed due to lack of physical investigation.The issue will be monitored for trending purposes.Investigation will be revisited if additional information is received.Mimb review.Assess severity of complaint case to determine if additional actions or inputs are required for inclusion in the medical assessment.Determine if a medical assessment will be performed based on a review of the complaint details and further input from the medical director/designee.Reviewed during mimb.A medical investigation will be performed.Proceed based on information provided or available for the investigation; if no relevant clinical information is provided, recommend closure.Approved by dr.Luca orlandini and/or j.Templeton, medical director.A review of relevant clinical/medical information in the reported issue, inclusive of technique and patient information, to include, but not limited to: ¿patient information ¿surgical procedure/post-operative care review ¿device labeling (including technique guides, ifus, etc.) conclusion: based on the information provided the acute pain experienced by the patient was likely due to the re-tear of the repaired supraspinatus.C-0301141: the root cause of the fatigue, fever and pain could not be determined with the information provided, however the patient¿s medical history is significant for comorbidities which cannot be ruled out as possible contributing factors.Per the patient¿s medical record the physician stated that it ¿is unlikely that there is a foreign body reaction from graft.Pain likely caused by new exercised by the new therapist,¿ and not a mal performance of the s&n devices.The patient impact beyond the reported issues cannot be concluded.No further medical assessment is possible at this time based on the information provided.Approved by justin templeton, md 4/12/2020.

• Brand Name: REGENETEN PATCH
• 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: 9936138
• MDR Text Key: 186836559
• Report Number: 3003604053-2020-00023
• Device Sequence Number: 1
• Product Code: OWY
• 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: Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 02/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2020
• 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?: No
• Date Manufacturer Received: 02/14/2023
• 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): Other
• Patient Age: 49 YR
• Patient Sex: Female