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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. BIOINDUCTIVE IMPLANT W/ARTH DEL LRG; MESH, SURGICAL, COLLAGEN, ORTHOPAEDICS, REINFORCEMENT OF TENDON

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SMITH & NEPHEW, INC. BIOINDUCTIVE IMPLANT W/ARTH DEL LRG; MESH, SURGICAL, COLLAGEN, ORTHOPAEDICS, REINFORCEMENT OF TENDON Back to Search Results
Catalog Number 4566
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Cyst(s) (1800); Fluid Discharge (2686); Swelling/ Edema (4577)
Event Date 03/01/2023
Event Type  Injury  
Manufacturer Narrative
H10: internal complaint reference: case (b)(4).
 
Event Description
It was reported that, approximately, a month and half after an arthroscopy where a regeneten bioinductive implant was used, a raised sack appeared on the intra lateral portal of the patient.Synovial fluid was draining out of the sack with some chunks.When the sack was decompressed and then abducted, particles could be seen.It is unknown how the injury was treated or the patient's outcome.
 
Manufacturer Narrative
H10: internal complaint reference (b)(4).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.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specifications upon release for distribution.A complaint history review found similar reported events.The instructions for use were reviewed and found to include conditions of off label use and technique specifics, as well as precautions and warnings related to the use of the device.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 three undated photos of the ¿raised sack¿ were provided for review and confirm the reported.Based on the limited information provided no clinical factors were found which would have contributed to the reported event.While it was reported that the fluid was drained from the patient, it is unknow if the reported ¿particles¿ were removed from the patient.The regeneten bioinductive implant, bone anchors, and tendon anchors are implantable; thus, biocompatibility is not an issue.If retained, micro-motion or movement cannot be predicted.There is potential risk for tissue inflammation and/or pain.The root cause of the reported event could not be determined due to the limited clinical information provided.Based on the limited information provided we are unable to conclude on factors known to contribute to the alleged report.No containment or corrective actions are recommended at this time.H11: corrected information in h6 (health effect - clinical & impact code).
 
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Brand Name
BIOINDUCTIVE IMPLANT W/ARTH DEL LRG
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 Key16950213
MDR Text Key315438960
Report Number3003604053-2023-00022
Device Sequence Number1
Product Code OWY
UDI-Device Identifier00885556735664
UDI-Public885556735664
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K140300
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 02/14/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue Number4566
Device Lot Number2082935
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 04/27/2023
Initial Date FDA Received05/17/2023
Supplement Dates Manufacturer Received02/12/2024
Supplement Dates FDA Received02/14/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/04/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other;
Patient SexMale
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