MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH SIDUS® STEM-FREE SHOULDER, HUMERAL HEAD, 46-16; SHOULDER PROSTHESIS

Model Number	N/A
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Joint Dislocation (2374)
Date of Event	07/03/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that patient with total shoulder prosthesis has been revised four (4) years after initial surgery due to pain, liner fracture and dislocation.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
(b)(4).G2: foreign: switzerland.D10: associated products: item reference:01.04440.013, item name:anaverse¿ glenoid, liner, m, humeral head, 46-16, item lot:2977500.Item reference:01.04440.033, item name:dpsc screw, 33mm 46-16, item lot:2994817.Item reference:01.04440.036, item name:dpsc screw, 36mm, 46-16, item lot:2994818.Item reference:01.04555.120, item name:sidusâ® stem-free shoulder, humeral anchor, uncemented, m, 46-16, item lot:2960619.Item reference:01.04440.003, item name:anaverse¿ glenoid, baseplate, m, 15mm, 46-16, item lot:2994240.Investigation of this incident is currently ongoing.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.
Event or Problem Description
Upon review of this complaint from an investigation perspective, it is now considered that the sidus® stem-free shoulder, humeral head, within this complaint does not impact the reported event of liner fracture and dislocation.Hence this report will be voided.
Additional Manufacturer Narrative
(b)(4).Upon review of this complaint from an investigation perspective, it is now considered that the sidus® stem-free shoulder, humeral head, within this complaint does not impact the reported event of liner fracture and dislocation.Given the above information this medwatch will be voided.

• Brand Name: SIDUS® STEM-FREE SHOULDER, HUMERAL HEAD, 46-16
• Common Device Name: SHOULDER PROSTHESIS
• Manufacturer (Section D): ZIMMER SWITZERLAND MANUFACTURING GMBH; 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: 17441502
• Report Number: 0009613350-2023-00432
• Device Sequence Number: 2711677
• Product Code: HSD
• UDI-Device Identifier: 00889024415942
• UDI-Public: (01)00889024415942(17)290131(10)2980304
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K171858
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2023
• 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): 09/14/2023

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: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: 01.04555.460
• Device Lot Number: 2980304
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/26/2023
• 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: 07/10/2023
• Supplement Date Received by Manufacturer: 09/08/2023
• Initial Report FDA Received Date: 08/02/2023
• Supplement Report FDA Received Date: 09/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/14/2019
• 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
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Male