MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TM REVERSE 12MM ÿ 130MM LENGTH HUMERAL STEM; SHOULDER PROSTHESIS, REVERSE CONFIGURATION/EXTREMITIES

Catalog Number	00434901213
Medical Device Problem Code	Material Erosion (1214)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Muscle Weakness/Atrophy (1967); Pain (1994); Loss of Range of Motion (2032); Nonunion/Delayed-union Bone Fracture (2369); Joint Dislocation (2374); Osteolysis (2377); Unequal Limb Length (4534); Bone Notching (4890)
Date of Event	04/03/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent an initial reverse total shoulder on an approximately four (4) years and seven (7) months ago.Subsequently, the patient underwent a revision surgery approximately one (1) year and five (5) years ago due to increased pain and loss of range of motion due to the implant disassociating with clavicular nonunion and scapular malalignment.
Additional Manufacturer Narrative
(b)(4).D10: medical products: item#: 00435003600, 36mm vit e liner +0mm; lot#: 64375020.Item#: 115395, comp rvs cntrl 6.5x25mm; lot#: 916180.Item#: 180551, comp lk scr 3.5hex 4.75x20 st; lot#: 428110.Item#: 180553, comp lk scr 3.5hex 4.75x30 st; lot#: 457940.Item#: unknown, unknown tm rev humeral component; lot#: unknown.Item#: 115310, comp rvrs shldr glnsp std 36mm; lot#: 668560.Item#: 010000589, comp rvrs 25mm bsplt ha+adptr; lot#: 919300.G2: foreign: japan.G2: literature: yuki yoshida, takeshi ikegami, jos case reports, https://doi.Org/10.1016/j.Joscr.2025.02.001.H6: component codes: mechanical (g04) - stem.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history record(s) identified no deviations or anomalies during manufacturing.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: a reverse shoulder arthroplasty was placed in the patient on (b)(6) 2021 at the age of 73.The final routine checkup in 2022 (month unknown) noted, bone resorption of the greater tubercle and scapular notching.At 75 years of age, she began experiencing frequent falls due to muscle weakness eventually requiring admission to a care facility.After admission, there was no documented history of falls or trauma.However, a palpable mass was observed in her right shoulder.Although she experienced pain during shoulder movement while receiving care, the condition was initially monitored without intervention.Her shoulder pain during caregiving gradually worsened, and she was referred to hospital at 77 years of age.On (b)(6) 2024, the patient presented to the emergency department complaining of shoulder pain.Radiography and computed tomography revealed that the palpable mass was the dislocated glenosphere at the anterior surgical site, along with glenosphere dissociation.Revision occurred on (b)(6) 2024 when the glenosphere, liner, baseplate and screws were revised and the humeral stem was retained.A definitive root cause cannot 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.

• Brand Name: TM REVERSE 12MM ÿ 130MM LENGTH HUMERAL STEM
• 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: 23378391
• Report Number: 0001822565-2025-03842
• Device Sequence Number: 12967681
• Product Code: PHX
• UDI-Device Identifier: 00889024268951
• UDI-Public: (01)00889024268951(17)300713(10)64759372
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K130661
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Literature,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/23/2025

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?: Yes
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 00434901213
• Device Lot Number: 64759372
• 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: 03/18/2025
• Initial Report FDA Received Date: 10/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/15/2020
• 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: Required Intervention; Hospitalization
• Patient Age: 77 YR
• Patient Sex: Female