MAUDE Adverse Event Report: EMBODY, INC EMBODY TAPESTRY BIOINTEGRATIVE IMPLANT WITH INSERTION SLEEVE; MESH, SURGICAL, COLLAGEN, ORTHOPAEDICS, REINFORCEMENT OF TENDON

Catalog Number	TS-5040-02
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Muscle/Tendon Damage (4532)
Date of Event	03/03/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the product remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.If any further information which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
It was reported that the patient was initially implanted with an embody implant approximately nine (9) months ago as part of a clinical study.Subsequently, it was reported that during their 6-month follow up appointment that the patient was experiencing pain and a sudden tearing sensation while putting on a bathrobe.An ultrasound showed either nonhealing or pulling off the tendon.Patient was prescribed physical therapy and there are currently no plans for surgical intervention.Attempts have been made and no further information has been provided.

• Brand Name: EMBODY TAPESTRY BIOINTEGRATIVE IMPLANT WITH INSERTION SLEEVE
• Common Device Name: MESH, SURGICAL, COLLAGEN, ORTHOPAEDICS, REINFORCEMENT OF TENDON
• 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: 25652984
• Report Number: 3015543569-2026-00001
• Device Sequence Number: 15912378
• Product Code: OWY
• UDI-Device Identifier: 00810063820060
• UDI-Public: (01)00810063820060(17)270130(10)T581L
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K201572
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/29/2026

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
• Operator of Device: Lay User/Patient
• Device Catalogue Number: TS-5040-02
• Device Lot Number: T581L
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/11/2026
• Initial Report FDA Received Date: 06/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/30/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Sex: Female