MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMP RVS CNTRL 6.5X35MM ST/RST; SHOULDER PROSTHESIS, REVERSE CONFIGURATION/EXTREMITIES

Catalog Number	115397
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Failure of Implant (1924); Joint Dislocation (2374); Foreign Body In Patient (2687); Metal Related Pathology (4530)
Date of Event	09/10/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10: medical products: item#: 110032410, comp aug mini bsplt w tpr sm; lot#: 64362990; item#: 180554, comp lk scr 3.5hex 4.75x35 st; lot#: 628420; item#: 180552, comp lk scr 3.5hex 4.75x25 st; lot#: 461960; item#: 00434901613, 16mm a 130mm length humeral stem; lot#: 64290746; item#: 00434904006, 40mm a +6mm offset poly liner; lot#: 63842516; item#: 118000, 25mm versa-dial taper adaptor; lot#: 806300; item#: 110030777, +3mm lateral offset 40mm diameter glenosphere; lot#: 64492558; item#: 00434903912, 12mm humeral stem spacer; lot#: 64566827.H3: customer has indicated that the product will not be returned to zimmer biomet for investigation, as the product location is unknown.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 right shoulder arthroplasty approximately six (6) years and one (1) month ago.The patient has had a history of multiple revisions of their right shoulder.Subsequently, the patient underwent a revision surgery approximately six months ago due to the screw fracturing causing the implant to loosen and the patient's shoulder to dislocate.There was metallosis found but no signs of infection, the surgeon however did do an infection workup that was found to be negative.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated: b4; b5; d2; g2; g3; g6; h1; h2; h3; h6.H10: related report numbers: 0001825034-2025-00825.0001825034-2025-00827.0001825034-2025-00828.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 related to the reported event.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: during a follow up on 10-jun-2024, noted recurrent dislocations, discovered the three screws holding baseplate had broken.During stage 1 revision on (b)(6) 2024; stage 1 revision, patient presented with instability, baseplate loosening, and screw breakage.Infectious workup negative.Minimal anterior soft tissues and thin deltoid noted.Humeral implant dislocating with tug test.Paper thin proximal cortical humeral bone.Gross motion of the baseplate and glenosphere observed.Able to remove broken screws centrally, superiorly, and inferiorly from the baseplate ¿these were completely broken and sheared off from their tips.¿ ¿the tips of the screws were not visible, so to limit further bone loss, i felt that these were not retrievable.¿ cultures obtained; however, no gross sign of infection noted.Metallosis tissue removed with a femoral canal brush.Depuy prostalac spacer and stimulan beads placed.Radiographs were not provided.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.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: COMP RVS CNTRL 6.5X35MM ST/RST
• Common Device Name: SHOULDER PROSTHESIS, REVERSE CONFIGURATION/EXTREMITIES
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 21690058
• Report Number: 0001825034-2025-00826
• Device Sequence Number: 8820256
• Product Code: PHX
• UDI-Device Identifier: 00880304677098
• UDI-Public: (01)00880304677098(17)291009(10)268500
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K193373
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/05/2025

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: Health Professional
• Device Catalogue Number: 115397
• Device Lot Number: 268500
• 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: 02/26/2025
• Supplement Date Received by Manufacturer: 07/11/2025
• Initial Report FDA Received Date: 03/25/2025
• Supplement Report FDA Received Date: 08/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/09/2019
• 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; Hospitalization
• Patient Age: 70 YR
• Patient Sex: Male