EMBODY TAPESTRY BIOINTEGRATIVE IMPLANT WITH INSERTION SLEEVE
Received Jun 29, 2026 · Event occurred Mar 3, 2026
Report 3015543569-2026-00001 · MDR key 25652984
Device
Generic name
Mesh, Surgical, Collagen, Orthopaedics, Reinforcement Of Tendon
Manufacturer
Embody, IncModel number
NICatalog number
TS-5040-02
Lot number
T581L
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
NA · Female
- Pain
- Muscle/Tendon Damage
Narrative
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.
Description of Event or Problem
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.