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

Catalog Number UNKNOWN

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

Patient Problems Foreign Body Reaction (1868); Pain (1994)

Event Date 04/04/2019

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference: (b)(4).Article: barad, s.J.(2019).Severe subacromial-subdeltoid inflammation with rice bodies associated with implantation of a bio-inductive collagen scaffold after rotator cuff repair.Journal of shoulder and elbow surgery, 28(6), e190-e192.Doi: https://doi.Org/10.1016/j.Jse.2019.02.019.

Event Description

It was reported that on literature review "severe subacromial-subdeltoid inflammation with rice bodies associated with implantation of a bio-inductive collagen scaffold after rotator cuff repair," 1 patient had an acute, massive swelling developed in the subacromial space associated with intense pain after 4 months a rotator cuff repair with a regeneten bio-inductive implant.Magnetic resonance imaging (mri) showed a healed rotator cuff tendon with significant swelling with particulate debris in the subacromial-subdeltoid bursa.The particulate debris resembled rice bodies.The patient underwent surgery to perform washout, debridement, and placement of tubes for drainage.The patient received intravenous antibiotics while final cultures were awaited.With negative culture findings, the antibiotics were stopped and the patient began physical therapy.At 4 weeks, the swelling was completely gone.At 3 months¿ follow-up (7 months after rotator cuff repair), the pain had nearly completely disappeared and the patient had returned to work.

Manufacturer Narrative

H10: internal complaint reference (b)(4).H3, h6: a device deficiency was not identified, and the root cause of the reported event could not be determined since the device was not returned for evaluation.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 could not be conducted.Insufficient product identification information was provided, and thus, an instruction for use review could not be conducted.Insufficient product identification information was provided and thus a risk management review could not be conducted.A clinical review states per case details, it has been communicated ¿no further information is available.¿ as of the date of this medical investigation, the requested clinical documentation has not been provided; therefore, there were no clinical factors found which would have definitively contributed to the event.Consequently, without clinically relevant patient-specific supporting documentation, a thorough medical investigation could not be performed.The images provided in the article have been interpreted within the text; therefore, no further analysis of the images is required.The root cause and/or patient outcome beyond that which was documented in the article (including treatments employed, report of resolved swelling with ¿pain had nearly completely disappeared, and the patient had returned to work¿) could not be confirmed nor concluded; therefore, no further medical assessment can be rendered.Please refer to the instructions for use for recommendations on proper use of the device and potential troubleshooting methods to prevent future reoccurrence of the reported event.No containment or corrective actions are recommended at this time.If the product associated with this event is returned at a future date, this investigation will be reopened for evaluation.Correction in h6 (health effect - impact code).

• Brand Name: UNKNOWN REGENETEN BIOINDUCTIVE IMPLANT SYSTEM IMPL
• 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: 16537669
• MDR Text Key: 311230300
• Report Number: 3003604053-2023-00007
• 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: Study,Literature,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 07/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2023
• 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?: Yes
• Date Manufacturer Received: 07/13/2023
• 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; Required Intervention; Hospitalization
• Patient Age: 48 YR
• Patient Sex: Male