MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TM RVS BASE PLT 25MM POST +2; SHOULDER PROSTHESIS, REVERSE CONFIGURATION/EXTREMITIES

Catalog Number	00434902502
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Extraskeletal ossification (1428); Pain (1994); Tendinopathy (4887)
Date of Event	08/10/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10: medical products: item#: 00434903611, tm reverse 36mm glenosphere; lot#: 64107232.Item#: 211216, compr srs prox bdy - sm 58mm; lot#: 222230.Item#: 211237, compr srs mod stem - 10x100mm; lot#: 321180.Item#: 115370, comp rvs tray co 44mm; lot#: 795990.Item#: ep-115393, e1 44-36 std hmrl brng; lot#: 247950.Item#: 211228, compr srs mod rgx aug - sm; lot#: 978020.H3: customer has indicated that the product will not be returned to zimmer biomet for investigation, as the product remains implanted in the patient.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that the patient underwent an initial left reverse total shoulder arthroplasty approximately six (6) years and six (6) months ago.Subsequently, the patient received three separate cortisone injections due to pain and signs of tendonitis.The event was reported to be resolved approximately one (1) year and three (3) months ago.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated/corrected: a1; a2; b4; b5; b7; d2; e1; e2; e3; g1; g2; g3; g6; h1; h2; h6; h10 if any further information is found that 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.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated/corrected: b4; b5; d2; d4; g1; g3; g6; h1; h2; h3; h4; h6.The reported event is not confirmed.Review of the reported event by a health care professional found that tendonitis is the inflammation or irritation of the tendons, typically caused by repetitive motion, overuse, and pressure to the bursae.Symptoms can include pain, tenderness, swelling, stiffness, decreased movement, and/or redness at or around the joint involved.This condition can impact the patient's ability to use the joint fully, decrease overall activities of daily living (adls), range of motion (rom) of the joint, and quality of life, while increasing the need for possible over-the-counter (otc) medications for swelling and pain control.Treatment can consist of otc medications, prescribed pain medications, physical therapy, rest, ice, elevating the affected joint, and steroid injections.Heterotopic ossification (ho) is the abnormal and rapid growth of bone that forms within soft tissue as the result of heredity, trauma, surgical history, or diseases of a joint.The rapid and irregular growth of bone often causes a sharp or jutted structure to form, which can result in pain and irritation to the surrounding tissues, or the patient can remain asymptomatic.Radiation or nonsteroidal anti-inflammatory medications are often provided to prevent ho formation.The only treatment, if necessary, is surgical excision or shaving/smoothing out the excess bone.As timeframes of onset differ due to individual contributing factors, a specific timeframe of expected occurrence cannot be established.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.The root cause of the reported event was determined to be unrelated to the device.If any further information is found that 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: TM RVS BASE PLT 25MM POST +2
• Common Device Name: SHOULDER PROSTHESIS, REVERSE CONFIGURATION/EXTREMITIES
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 23099856
• Report Number: 0001822565-2025-03506
• Device Sequence Number: 8765416
• Product Code: PHX
• UDI-Device Identifier: 00889024269033
• UDI-Public: (01)00889024269033(17)290131(10)64227258
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K130661
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Study,Literature,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/25/2025

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
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 00434902502
• Device Lot Number: 64227258
• 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: 08/21/2025
• Supplement Date Received by Manufacturer: 09/18/2025; 11/25/2025
• Initial Report FDA Received Date: 09/19/2025
• Supplement Report FDA Received Date: 10/16/2025; 12/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/17/2019
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11 NARRATIVE.
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Sex: Female
• Patient Weight: 65 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White