MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH SIDUS STEM-FREE SHOULDER, HUMERAL ANCHOR, UNCEMENTED, M; EXTREMITIES PROSTHESIS

Model Number	01.04555.120
Medical Device Problem Code	Human-Device Interface Problem (2949)
Health Effect - Clinical Codes	Pain (1994); Loss of Range of Motion (2032); Arthralgia (2355)
Date of Event	04/18/2022
Type of Reportable Event	Death
Additional Manufacturer Narrative
(b)(4).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.Concomitant medical products: cannulated drill with stop 6 mm, catalog: 47430706100, lot: 65092392.2.5mm pin, catalog: 47430902501, lot: 65038433.2.5mm drill, catalog: 47430904601, lot: 65157512.Multiple mdr reports were filed for this event, please see associated reports: 0009613350-2022-00274, 0009613350-2022-00275.
Event or Problem Description
It was reported that a patient underwent a revision surgery due to pain and lack of motion.Head and anchor were revised.Attempts have been made and no further information has been provided yet.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.As neither the products nor any images of the products were received, visual and dimensional evaluations could not be performed.Review of the device history records identified no deviations or anomalies during manufacturing.Therefore, the investigation did not identify a nonconformance or a complaint out of box (coob).The devices are used for treatment.Medical records were not provided.A definitive root cause related to the reported pain and lack of range of motion 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: SIDUS STEM-FREE SHOULDER, HUMERAL ANCHOR, UNCEMENTED, M
• Common Device Name: EXTREMITIES 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: 14352088
• Report Number: 0009613350-2022-00274
• Device Sequence Number: 5010229
• Product Code: KWS
• UDI-Device Identifier: 00889024397170
• UDI-Public: (01)00889024397170(17)280430(10)2951615
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: N/A
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/30/2022

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 Model Number: 01.04555.120
• Device Catalogue Number: 01.04555.120
• Device Lot Number: 2951615
• 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: 04/18/2022
• Supplement Date Received by Manufacturer: 04/04/2022
• Initial Report FDA Received Date: 05/11/2022
• Supplement Report FDA Received Date: 08/31/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/16/2018
• 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: SEE H10 NARRATIVE
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown
• Patient Weight: 104 KG