MAUDE Adverse Event Report: SMITH & NEPHEW, INC. UNKN REGENETEN BIOINDUCTIVE IMPLANT SYSTEM DEV; 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); Failure of Implant (1924); Pain (1994)

Event Date 05/10/2021

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference: (b)(4).

Event Description

It was reported that the surgeon found a rice body response to a patient after a regeneten bioinductive patch was implanted.Additionally, cultures came back negative.It is unknown if a treatment was performed or if a revision surgery is planned.No injuries reported.

Manufacturer Narrative

H10: h3, h6: the reported device was not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional testing could not be performed.Insufficient product identification information was provided and thus a manufacturing record review, complaint history review, risk management review, and an instructions for use/device labeling review could not be conducted.Based on the information available, there were no indications to suggest that the product did not meet manufacturing specification upon release for distribution.There was no relationship found between the device and the reported event.After three requests no relevant clinical information has been provided for inclusion in this medical investigation.Without the requested clinical information, a thorough medical investigation cannot be rendered nor can the root cause of the rice body response be determined.Based on the information provided, the patient, " cultures," were reported as negative, however, no supporting clinical documentation was provided.Per report, it is unknown if a treatment was performed or if a revision surgery is planned.Therefore, the impact to the patient beyond that which has already been reported cannot be determined.Should any additional clinical information be provided, this compliant will be re-assessed.The complaint was not confirmed.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.

Event Description

It was reported that on "subacromial-subdeltoid bursitis with rice bodies after rotator cuff repair with a collagen scaffold implant" one year after a patient was treated for a partial-thickness tear/full-thickness tear mix with regeneten, they returned with dull and aching pain, they felt their shoulder was swollen.The mri showed debris in the bursa, containing small bodies of intermediate density.The patient was treated via a subacromial debridement, and at 1 year post procedure, the patient was able to return to work.

Manufacturer Narrative

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 without supporting clinical documentation the information provided is insufficient to determine whether the reported patient¿s symptoms, signs or outcome are due to a pre-existing or concurrent medical or surgical condition or procedure, or to an adverse reaction to or experience with the device, one or more of its components, or its intended therapeutic action.Additionally, the images documented/referenced in the article (per the author/writer) have been interpreted within the text.Therefore, further interpretation of the provided images is not required.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.

• Brand Name: UNKN REGENETEN BIOINDUCTIVE IMPLANT SYSTEM DEV
• 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 ; 5123913905
• MDR Report Key: 12393473
• MDR Text Key: 268991686
• Report Number: 3003604053-2021-00243
• 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: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2021
• 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: 05/03/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Hospitalization; Required Intervention
• Patient Age: 44 YR
• Patient Sex: Male