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

Catalog Number 4565

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Pain (1994); Skin Inflammation/ Irritation (4545)

Event Date 03/31/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that after procedure, where regeneten bioinductive implant was used, the patient had pain and irritation on (b)(6) 2021.On a second surgery, it was noticed that the device become dislodged and was not secured to the supraspinatus tendon.It had bunched up and was partially attached to the acromion.The implant, bone anchors and tendon anchors were removed.The patient outcome is unknown.

Manufacturer Narrative

Internal complaint reference (b)(4).B5 and d4: updated.

Event Description

It was reported that on (b)(6) 2021 patient had a left shoulder arthroscopic rotator cuff repair using a regeneten patch.After this the patient presented pain and had to be treated with medication, injections and phyisical therapy.On (b)(6) 2021 the patient had a revision surgery where there was evidence of a midsubstance rupture of the bio inductive patch with tissue flipped on itself in the lateral glutter and also a ridge on the acromion which may have corresponded to the contact of the graft.The rupture of the patch was debrided with a combination of a shaver and grasper from the lateral portal, the 2 bone staples were removed and the soft tissue staples were also removed with a combination of a grasper and a shaver.The ridge was smoothed with a shaver.After this procedure patient presented pain again, medications were also provided.Current status of the patient is unknown.

• Brand Name: BIOINDUCTIVE IMPLANT W/ARTH DEL MED
• 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: 12445090
• MDR Text Key: 270482165
• Report Number: 3003604053-2021-00246
• Device Sequence Number: 1
• Product Code: OWY
• UDI-Device Identifier: 00885556735657
• UDI-Public: 885556735657
• 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: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/10/2023
• Device Catalogue Number: 4565
• Device Lot Number: A8686
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/24/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/10/2020
• 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): Required Intervention