MAUDE Adverse Event Report: EMBODY, INC TAPESTRY 40X30MM; MESH, SURGICAL

Catalog Number	TP-4030-01
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Bursitis (4832)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient had an unknown procedure and experienced right hip pain, trochanteric bursitis, and received a steroid injection.No additional patient consequences were reported.
Additional 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.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: a2, a3, a4, b4, b5, b7, d6a, g2, g3, g6, h1, h2, h6, h11 corrected sections: d1, d2,d4, e1, e2, e3 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.
Event or Problem Description
It was reported that the patient experienced right hip pain, trochanteric bursitis, and received a steroid injection post initial implantation.No additional patient consequences were reported.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, d4, g3, g6, h2, h3, h4, h6, h11 no product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.Medical records were not provided.Crf was reviewed by a health care professional.Review of the crf identified the following: right hip pain, trochanteric bursitis with treatment of steroid injection a definitive root cause cannot be determined.No corrective actions, preventive actions, or field actions resulted after investigation of this event.The reported event is unconfirmed.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 or Problem Description
No further event information is available at the time of this report.

• Brand Name: TAPESTRY 40X30MM
• Common Device Name: 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: 21696860
• Report Number: 3015543569-2025-00002
• Device Sequence Number: 12955166
• Product Code: OWY
• UDI-Device Identifier: 00810063820053
• UDI-Public: (01)00810063820053(17)251229(10)T-250
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K201572
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/10/2025

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
• Device Expiration Date: 12/29/2025
• Device Catalogue Number: TP-4030-01
• Device Lot Number: T-250
• 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: 03/17/2025
• Supplement Date Received by Manufacturer: 04/16/2025; 09/03/2025
• Initial Report FDA Received Date: 03/26/2025
• Supplement Report FDA Received Date: 04/28/2025; 09/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/29/2023
• 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
• Patient Age: 63 YR
• Patient Sex: Male
• Patient Weight: 90 KG