MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH ANATOMICAL SHOULDER¿¢ DOMELOCK®, DOME, CENTRIC; SHOULDER PROSTHESIS

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Extravasation (1842); Pain (1994); Loss of Range of Motion (2032); Scar Tissue (2060); Joint Impingement (4834)
Date of Event	01/15/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0009613350-2023-00301 ; 0009613350-2023-00303 ; 0009613350-2023-00304.G2: foreign- switzerland.D10: associated products: item number: 01.04201.103, item name: anatomical shoulder¿, humeral stem, uncemented, ø 10.5, 100 mm, item lot: 2835291.Item number: 01.04214.370, item name: anatomical shoulderâ¿¢, glenoid, pegged, cemented, m, item lot: 2841275.Item number: 01.04212.445, item name: anatomical shoulder¿ domelock®, humeral head, ø44-16, r=24.4mm, m, item lot: 2813408.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 that patient with left total shoulder replacement underwent an additional surgery due to frozen shoulder, impingement syndrome, and unknown cement leaked into the spinoglenoid notch.No additional complications have been reported.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated: b4, b5, d2, d9, g1, g3, g6, h1, h2, h3, h6, h10.The devices remain implanted; visual and dimensional evaluations could not be performed.A review of the device manufacturing records confirmed no abnormalities or deviations that could be related to the reported event.Devices are used for treatment.Medical records and radiographs were provided and reviewed by a health care professional.The review identified an initial left total shoulder replacement on (b)(6), 2016.Subsequently, on (b)(6), 2018, the patient underwent an additional surgery due to frozen shoulder, impingement syndrome, and unknown cement that leaked into the spinoglenoid notch.No additional complications have been reported at the 7 year follow-up and the patient reported to be very satisfied.Two x-ray views of the left shoulder demonstrate a left shoulder arthroplasty with radiolucent glenoid component.No evidence for hardware failure or loosening and no fracture is seen.Possible rotator cuff repair.Based on the received medical records, a potential cause appears to be the cement leakage into the spinoglenoid notch.Nevertheless, with the available information, 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: ANATOMICAL SHOULDER¿¢ DOMELOCK®, DOME, CENTRIC
• 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: 17168619
• Report Number: 0009613350-2023-00302
• Device Sequence Number: 15242288
• Product Code: PHX
• UDI-Device Identifier: 00889024485006
• UDI-Public: (01)00889024485006(17)210331(10)2853488
• 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: 2016
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/31/2023

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?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 03/31/2021
• Device Model Number: N/A
• Device Catalogue Number: 01.04227.005
• Device Lot Number: 2853488
• 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: 05/23/2023
• Supplement Date Received by Manufacturer: 08/30/2023
• Initial Report FDA Received Date: 06/21/2023
• Supplement Report FDA Received Date: 08/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/22/2016
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Female
• Patient Weight: 53 KG