MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH ANATOMICAL SHOULDER DOMELOCK, DOME, CENTRIC; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Model Number	N/A
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Failure of Implant (1924); Subluxation (4525)
Date of Event	11/25/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10 ¿ medical devices: item#: 01.04201.123, lot#: 2979183, item name: anatomical shoulder, humeral stem, uncemented, 12, 100 mm i; item#: 113952, lot#: 692830, item name: sm hybrid glenoid base 4mm ; item#: 01.04212.465, lot#: 2902802, item name: anatomical shoulder domelock, humeral head, 46-16, r=26.1mm.G2 ¿ foreign: belgium.Multiple mdr reports were filed for this event, please see associated reports: 0009613350 - 2023 - 00520.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 the patient underwent an initial shoulder arthroplasty and approximately 2 years later a revision surgery was performed due to instability of the shoulder.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 information.No product was returned or pictures provided; 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.Report from clinical study was received and reviewed from a health care professional.The patient underwent a right anatomical shoulder arthroplasty due to omarthrosis.Subsequently, the patient underwent an open rotator cuff repair due to a rupture of the cranial fibers of the subscapularis and extensive interstitial cleavage tear of the supraspinatus; no device was revised during the procedure.Later, the patient underwent a revision to a reverse total shoulder for instability and two events of luxation: all components, except for stem, were revised.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
It was reported that the patient underwent an initial shoulder arthroplasty.Subsequently, the patient underwent an open rotator cuff repair due to a rupture of the cranial fibers of the subscapularis and extensive interstitial cleavage tear of the supraspinatus; no device was revised during the procedure.Approximately 2 years later a revision surgery was performed due to instability and luxation of the shoulder.Attempts have been made and no further information has been provided.

• Brand Name: ANATOMICAL SHOULDER DOMELOCK, DOME, CENTRIC
• Common Device Name: SHOULDER PROSTHESIS, REVERSE CONFIGURATION
• 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: 17754524
• Report Number: 0009613350-2023-00519
• Device Sequence Number: 6664492
• Product Code: PHX
• UDI-Device Identifier: 00889024485006
• UDI-Public: (01)00889024485006(17)231130(10)2975075
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: K193099
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• 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): 10/12/2023

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 Expiration Date: 11/30/2023
• Device Model Number: N/A
• Device Catalogue Number: 01.04227.005
• Device Lot Number: 2975075
• 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: 08/24/2023
• Supplement Date Received by Manufacturer: 10/04/2023
• Initial Report FDA Received Date: 09/15/2023
• Supplement Report FDA Received Date: 10/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/12/2018
• 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: Required Intervention; Hospitalization
• Patient Age: 64 YR
• Patient Sex: Female
• Patient Weight: 54 KG