MAUDE Adverse Event Report: EMBODY, INC TAPESTRY 30X30MM W INTRO ANT; MESH, SURGICAL

Catalog Number TR-3030-21

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

Patient Problems Hypersensitivity/Allergic reaction (1907); Pain (1994); Loss of Range of Motion (2032)

Event Date 03/31/2023

Event Type  Injury  

Event Description

It was reported that the patient had an initial left shoulder arthroscopy.The patient complains of pain, stiffness, inflammation, decreased rom, bursitis, and an allergic reaction to the bovine-derived material of the implant.No additional patient consequences were reported.

Manufacturer Narrative

(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, d2, g3, g6, h1, h2, h4, h6, h11.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Device is used for treatment.The reported patient symptoms are confirmed via provided medical records, however, allergy is not comfirmed.Review of the available records identified the following: dr knudsen note left shoulder pain, stiffness, capsulitis, and possible inflammatory reaction to bio inductive collagen scaffold s/p left shoulder arthroscopic debridement, subacromial decompression with partial acromioplasty, and partial rotator cuff repair with placement of an embody tapestry collagen scaffold implant.Postop arthroscopy: sling for 4-5 days, pt starting at 1 week postop with limited progress at 3 months, severe pain since with decreased rom and hard stop, intermittent spasms, increased warmth mri report impression: postsurgical changes about the superior rotator cuff, supraspinatus tendinosis, mild glenohumeral degenerative joint disease, suspect tearing of superior labrum, nonspecific inferior glenohumeral ligament edema, narrowed acromiohumeral interval with mild subacromial spurring.Letter from siri & glimstad.Pdf additional shoulder conditions including inflammation, bursitis, and adhesive capsulitis.Systemic inflammation and rheumatic symptoms quickly returned postop due to allergic reaction to bovine derived material of implant.Additional shoulder conditions including inflammation, bursitis, and adhesive capsulitis.Systemic inflammation and rheumatic symptoms quickly returned postop due to allergic reaction to bovine derived material of implant.Device history record (dhr) was reviewed and no discrepancies were found.Root cause was unable to be determined.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

No further event information is available at the time of this report.

• Brand Name: TAPESTRY 30X30MM W INTRO ANT
• Type of Device: MESH, SURGICAL
• Manufacturer (Section D): EMBODY, INC; 4211 monarch way, suite 500; norfolk VA 23508
• Manufacturer (Section G): EMBODY, INC; 4211 monarch way, suite 500; norfolk VA 23508
• Manufacturer Contact: jennifer rapsavage ; 56 e bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 18651093
• MDR Text Key: 334660239
• Report Number: 3015543569-2024-00001
• Device Sequence Number: 1
• Product Code: OWY
• UDI-Device Identifier: 00810063820107
• UDI-Public: (01)00810063820107(17)230630(10)122234
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K220867
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/17/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2023
• Device Catalogue Number: TR-3030-21
• Device Lot Number: 122234
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/17/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/27/2022
• 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: 49 YR
• Patient Sex: Female