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

Catalog Number UNKNOWN

Device Problems Material Disintegration (1177); Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)

Patient Problems Failure of Implant (1924); Damage to Ligament(s) (1952); Pain (1994); Arthralgia (2355); Device Embedded In Tissue or Plaque (3165); Muscle/Tendon Damage (4532)

Event Date 12/01/2022

Event Type  Injury  

Event Description

It was reported that on (b)(6) 2022, a rotator cuff repair was performed on the patient's left shoulder using a regeneten implant (case(b)(4).Three months after surgery, the patient began experiencing pain in the joint.Medication was taken, however, the pain continued to increase throughout time.Six months after implantation, an mri was ordered by the surgeon due to the patient's ongoing pain.The mri revealed a new tear had formed in the area.The patient was only doing the allowed rehab at the moment, and working for very short periods of time.A subsequent mri arthrogram was performed and reviewed by a second, unaffiliated surgeon.It revealed a complete failure of the previous repair.A tear of 10% of the infraspinatus muscle was also noticed, a muscle that was fully intact at the time of the first surgery.At an unknown date, a second surgery was performed by the unaffiliated surgeon.He discovered the implant had disintegrated and fragments of it were floating around the joint.The bicep tendon as well as the subscapularis tendons had healed well.In contrast, the supraspinatus tendon, where the regeneten implant had been placed, had not healed.Instead, the original partial thickness supraspinatus tear converted to a complete tear after first surgeon repair.It was completely retracted and unrepairable.In addition, the patient declared that without his fully understanding, the first surgeon took down a perfectly ca ligament during his sub acromial decompression, and stated that the missing ligament has contributed to noticeable upward and forward migration of his shoulder head.The second surgeon removed all fragments of the implant during surgery.He also removed the remaining tendon staples (case-2023-00185686-2) and the unattached fiber wire sutures.The surgeon decided to leave the bone anchors from the transosseous equivalent repair embedded in the humeral head, since they were beginning to close cover.He believed the removal might cause more damage than retaining them.As of today, the patient continues experiencing pain in the deepest area of the cuff, for which he still has to take pain medication.It took almost a year after the first surgery, for the patient to return to his full job schedule.

Manufacturer Narrative

H10: internal complaint reference case(b)(4).

Manufacturer Narrative

Internal complaint reference(b)(4).A device deficiency was not identified, and the root cause of the reported event could not be determined due to the limited clinical information provided.Insufficient product identification information was provided and thus a manufacturing record review could not be conducted.Based on the information available, there were no indications to suggest that the product did not meet manufacturing specifications upon release for distribution.Insufficient product identification information was provided and thus a complaint history review and instruction for use could not be conducted.A risk management review found that the reported failure and/or harm was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.A clinical review states that it was reported the regeneten implant had disintegrated, it should be noted the regeneten is a bioinductive implant, designed to be completely absorbed within 6 months.The patient activity as well as the reported coracoacromial (ca) ligament takedown which caused an upward and forward migration of his shoulder head cannot be ruled out as possible contributing factors to the reported supraspinatus complete tear.No conclusion can be made on the impact of the regeneten on the underlying tendon.As well, it cannot be concluded there was a causal relationship between the implant and the 10% tear of the infraspinatus muscle.The patient impact is the pain and additional surgery.Based on the limited information provided a thorough medical assessment could not be performed; therefore, we are unable to conclude specific factors known to contribute to the alleged report.No containment or corrective actions are recommended at this time.

• Brand Name: UNKNOWN REGENETEN BIOINDUCTIVE IMPLANT SYSTEM INSTRUMENT
• 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: 18414193
• MDR Text Key: 331582109
• Report Number: 3003604053-2023-00093
• 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: Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• 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: 03/08/2024
• 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 Sex: Male