MAUDE Adverse Event Report: Zimmer GmbH ANN PH NAIL RT 8.5X260MM; Rod, Fixation, Intramedullary And Accessories

Catalog Number	47249626008
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Type of Reportable Event	Serious Injury
Event or Problem Description
A journal article was obtained on 10-mar-2026 that reported a retrospective study from the united states.The purpose of the study was to describe a novel technique for treatment of this unique patient population along with its risk of complications and reinfection in patients undergoing staged revision shoulder arthroplasty.The study reviewed 17 patients and 18 shoulders (1 bilateral) between january 2019 and december 2023 who underwent revision for suspected periprosthetic joint infection with proximal humeral bone loss noted preoperatively or at the time of surgery.After removal of the previous implants, a cement spacer was implanted using a osteoremedies prefabricated antibiotic humeral head, a steinmann pin, and a zimmer biomet straight humeral nail, and unspecified antibiotic cement to connect the pieces together.The spacer was press-fit into the humeral canal.Second stage reimplantation was considered in cases once patients had completed at least 6 weeks of antibiotics, they had negative inflammatory labs and there was no evidence of wound erythema or drainage.The mean age at the time of spacer placement was 63.6 ± 7.4 years, with an average follow-up of 22.8 ± 16.0 months (range 4-57 months) the study had 8 males and 9 females.It was reported through a journal article that a patient underwent stage 1 revision of unknown implants of the right shoulder on an unknown date due to infection and humeral fracture.The stage 1 implants consisted of a cemented humeral nail, steinmann pin, and cement spacer head.Approximately 3 months postop, the patient was revised to a reverse total shoulder with proximal humeral replacement due to pain.No intraop complications were identified.Due diligence has been completed for this complaint; to date all available additional information has been received.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
(b)(4)9: d6a.Implant date: between (b)(6) 2019 and (b)(6)2023.D10: item # unknown, baseplate taper adaptor, lot # 65988098, item # unknown, central screw 6.5x30mm, lot # 65979370, item # unknown, screw 4.75x25mm, lot # 66008641, item # unknown, screw 4.75x30mm, lot # 66150608, item # unknown, glenosphere 40mm, lot # 65804655, item # unknown, srs stem 10x75mm, lot # 920120, item # unknown, srs ic segment, lot # 427460, item # unknown, bearing 40mm+3, lot # 64653559, item # unknown, srs proximal body 48mm, lot # 65696594, item # unknown, steinman pin, lot # unknown.Literature - beady, n.D., guy, c., chalmers, p.N., joyce, c.D., tashjian, r.Z.(2025).Management of shoulder prosthetic joint infections with humeral bone loss using a customizable articulating long stem spacer (the frankenspacer).Jses reviews, reports, and techniques, volume 5 (issue 4), 685-692.Https://doi.Org/10.1016/j.Xrrt.2025.06.002.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4, g3, g6, h2, h3, h6, h11 the reported event was confirmed by review of medical records.Medical records were provided and reviewed by a health care professional.Review of the available records identified that the patient experienced significant pain affecting activities of daily living and quality of life and that her current level of function is unsatisfactory.No product was returned or pictures provided; a product evaluation could not be performed.The device history record was reviewed and no discrepancies relevant to the reported event were found.A definitive root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: ANN PH NAIL RT 8.5X260MM
• Common Device Name: Rod, Fixation, Intramedullary And Accessories
• Manufacturer (Section D): Zimmer GmbH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer (Section G): Zimmer GmbH; sulzer allee 8; sulzer industrie park; winterthur 8404
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; +1(574)526-0384
• MDR Report Key: 50773045
• Report Number: 0009613350-2026-00458
• Device Sequence Number: 9472454
• Product Code: HSB
• UDI-Device Identifier: 00889024506022
• UDI-Public: (01)00889024506022(17)290131(10)2983728
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K253749
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Literature,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/18/2026

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: 47249626008
• Device Lot Number: 2983728
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/10/2026
• Supplement Date Received by Manufacturer: 09/16/2026
• Initial Report FDA Received Date: 09/15/2026
• Supplement Report FDA Received Date: 09/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/31/2019
• 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: Hospitalization; Required Intervention
• Patient Age: 77 YR
• Patient Sex: Female
• Patient Weight: 90 LB