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

Catalog Number 72205307

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

Patient Problems Pain (1994); Loss of Range of Motion (2032); Swelling/ Edema (4577)

Event Date 07/20/2023

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that four months and four days (b)(6) after a rotator cuff repair surgery were a regeneten bioinductive implant was used, the patient returned to the hospital for review, and a subacromial fluid accumulation with severe edema was found in the patient after an mri was performed.The patient had right shoulder pain and limited movement for more than 1 year who failed conservative treatments.The rom was 120o/60o/30o at physical exam before the surgery.The patient was positive for intertubercular groove pain, jobe sign, belly press, lift-off, bear hug, hawkins test, neer test, o'brien.An small full thickness tear seen, grade 1 muscle atrophy.1 medial row and 2 lateral row anchors were placed.An mri was taken immediately post-operative, but did not showed any adverse reaction.The patient had a vas pain of 3-4 in the first 6 weeks after the surgery.After 3 weeks the vas pain decreased a bit, at 3 months the vas is about 2-3.The patient had physical therapy after the surgery (small pillow to support arm for 6 weeks, passive rom for those 6 weeks, active rom after 6 weeks).The patient's range of motion will be assess at 6 months.Dr (b)(6) will continue to monitor this patient at 6 months with another mri.

Manufacturer Narrative

H10: h3, h6: 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.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.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.H11: h2: corrected data on h6 (health effect - clinical codes and impact codes).

• Brand Name: BIOINDUCTIVE IMPLANT W ARTHRO 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 Key: 18383060
• MDR Text Key: 331292121
• Report Number: 3003604053-2023-00089
• Device Sequence Number: 1
• Product Code: OWY
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K140300
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 72205307
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/19/2024
• 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 Outcome(s): Other
• Patient Age: 58 YR
• Patient Sex: Female