MAUDE Adverse Event Report: ZIMMER BIOMET GMBH SWITZERLAND SIDUS STEM-FREE SHOULDER, HUMERAL HEAD, 44-16; PROSTHESIS, TOTAL ANATOMIC SHOULDER

Model Number	N/A
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Pain (1994); Metal Related Pathology (4530); Unspecified Tissue Injury (4559)
Date of Event	08/26/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient experienced pain about 9 years post initial hemi arthroplasty.Rotator cuff tear was confirmed on ct scan and revision surgery took place.During removal of the implants, it was noted there was metallosis and anchor had worn and disformed.Due diligence is in progress.
Additional Manufacturer Narrative
(b)(4).Report source-foreign.Concomitant medical products:-sidus stem-free shoulder, humeral head, 44-16,lot#2685032 item#0104555440.Multiple mdr reports were filed for this event, please see associated reports: 0009613350-2022-00454.Investigation of this incident is currently ongoing.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.
Additional Manufacturer Narrative
(b)(4).The following sections were updated: b4, b5, d9, g3, g6, h1, h2, h3, h6, h10.This follow-up report is being submitted to relay additional and/or corrected information.No products were returned.Visual examination of the provided information showed that the humeral anchor is fractured and pieces are missing.However, based on the investigation it is not possible to conclude if the damage occurred during time in vivo and if that may have contributed to the reported metallosis.Review of the device history records identified no deviations or anomalies during manufacturing.Devices are used for treatment.One radiograph was provided but was not reviewed by a health care professional as image on humeral anchors was unclear.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.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: SIDUS STEM-FREE SHOULDER, HUMERAL HEAD, 44-16
• Common Device Name: PROSTHESIS, TOTAL ANATOMIC SHOULDER
• Manufacturer (Section D): ZIMMER BIOMET GMBH SWITZERLAND; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer (Section G): ZIMMER SWITZERLAND MANUFACTURING 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: 15409634
• Report Number: 0009613350-2022-00455
• Device Sequence Number: 6952376
• Product Code: PKC
• UDI-Device Identifier: 00889024415935
• UDI-Public: (01)00889024415935(17)221130(10)2685032
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K171858
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/13/2023

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 Expiration Date: 11/30/2022
• Device Model Number: N/A
• Device Catalogue Number: 01.04555.440
• Device Lot Number: 2685032
• 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: 08/26/2022
• Supplement Date Received by Manufacturer: 01/18/2022
• Initial Report FDA Received Date: 09/13/2022
• Supplement Report FDA Received Date: 02/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/04/2012
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEEH10 NARRATIVE
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Prefer Not To Disclose