MAUDE Adverse Event Report: ZIMMER GMBH ANATOMICAL SHOULDER¿¢, HUMERAL STEM, UNCEMENTED, ø 12, 100 MM; PROSTHESIS, SHOULDER

Catalog Number	0104201123
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Extraskeletal ossification (1428); Pain (1994); Osteolysis (2377)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4): d10: item # 0104212465, anatomical shoulderâ¿¢ domelockâ®, humeral head, 㸠46-16, r=26.1mm, lot # 2889557.Item # 0104227005, anatomical shoulderâ¿¢ domelockâ®, dome, centric, lot # 2685048.Item # 0104214370, anatomical shoulderâ¿¢, glenoid, pegged, cemented, m, lot # 2898369.G2: report source switzerland.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.
Event or Problem Description
It was reported a patient had an initial left total shoulder arthroplasty on.Subsequently, at the two years follow up, radiographic imaging displayed osteolysis, heterotopic ossification, and subsidence.After approximately 5 years post implantation, the patient underwent a tooth extraction procedure and developed and underwent treatment for sepsis.Subsequently, approximately 6 years and 4 months post implantation the patient developed severe pain which resolved in the autumn of the same year.All implants remain in place.Attempts have been made and additional information on the reported event is unavailable at this time.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated: b4, g3, g6, h2, h3, h6, h10, h11.No product was returned or pictures provided; a product evaluation could not be performed.A review of the device manufacturing records confirmed no abnormalities or deviations.Review of the complaint histories identified additional similar complaints for the reported items and the part and lot combinations.It was reported a patient had an initial left total shoulder arthroplasty.Subsequently, at follow-up, radiographic imaging displayed osteolysis, heterotopic ossification, and subsidence.During the spring, the patient underwent a tooth extraction procedure and developed and underwent treatment for sepsis in.The patient developed severe pain which resolved in the autumn of the same year.All implants remain in place.Based on the available information, the reported of osteolysis and subsidence event can be confirmed, but a definitive root cause cannot be established.During the investigation process a review of the sterile certifications were reviewed and found to be conforming with no applicable deviations.Devices were verified to have gone through acceptable sterilization process following iso/aami/astm & eu published guidelines.There are multiple factors that may contribute to an infection that are outside the control of zimmer biomet, such as external factors, i.E.Hospital/surgical environment, provider related risk factors, and/or patient comorbidities/risk factors.As there are no indications of a product or process issues identified affecting implant safety or effectiveness, implanted products are not identified as the source or contributing to the reported infection.As timeframes for onset of heterotopic ossification differ due to individual contributing factors, a specific timeframe of expected occurrence cannot be established.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: ANATOMICAL SHOULDER¿¢, HUMERAL STEM, UNCEMENTED, ø 12, 100 MM
• Common Device Name: PROSTHESIS, SHOULDER
• Manufacturer (Section D): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur
• Manufacturer (Section G): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 21396169
• Report Number: 0009613350-2025-00061
• Device Sequence Number: 9328133
• Product Code: HSD
• UDI-Device Identifier: 00889024484924
• UDI-Public: (01)00889024484924(17)221031(10)2928554
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K193099
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Study,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/22/2025

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 Expiration Date: 10/31/2022
• Device Catalogue Number: 0104201123
• Device Lot Number: 2928554
• 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: 01/20/2025
• Supplement Date Received by Manufacturer: 05/12/2025
• Initial Report FDA Received Date: 02/18/2025
• Supplement Report FDA Received Date: 05/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/24/2017
• 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: Other
• Patient Age: 66 YR
• Patient Sex: Female
• Patient Weight: 75 KG