MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH ANATOMICAL SHOULDER DOMELOCK, HUMERAL HEAD, 46-16, R=26.1MM; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Model Number	N/A
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Codes	Pain (1994); Loss of Range of Motion (2032); Muscle/Tendon Damage (4532)
Date of Event	05/04/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10: item#0104227005; lot#2853488; item name#anatomical shoulder domelock, dome, centric.Item#0104214370; lot#2850137; item name#anatomical shoulder, glenoid, pegged, cemented, m.Item#0104211103; lot#2684383; item name#humeral stem cmntd 10.5-100.G2- switzerland.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.Multiple mdr reports were filed for this event, please see associated reports: 0009613350 - 2023 - 00285, 0009613350 - 2023 - 00288.
Event or Problem Description
It was reported a patient had an anatomical total shoulder arthroplasty.Subsequently, during the 7 year follow-up, reported moderate pain and limited range of motion.Patient underwent a conversion to a reverse total shoulder due to insufficient subscapular, supraspinatus and infraspinatus.All components were revised except for the stem and no additional information was provided.Attempts have been made and all additional information received has been included in this report.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional and/or corrected information.The devices were discarded; 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 were provided and reviewed by a healthcare professional.The review identified that the patient had an anatomical total shoulder arthroplasty.Subsequently, during the 7-year follow-up, the patient reported moderate pain and limited range of motion.Underwent a conversion to a reverse total shoulder due to insufficient subscapular, supraspinatus, and infraspinatus tendons.All components were revised except for the stem and no additional information was provided.Based on the received medical records, a potential cause appears to be an insufficiency of the subscapular, supraspinatus, and infraspinatus tendons.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, HUMERAL HEAD, 46-16, R=26.1MM
• 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: 17133940
• Report Number: 0009613350-2023-00286
• Device Sequence Number: 12374172
• Product Code: PHX
• UDI-Device Identifier: 00889024274884
• UDI-Public: (01)00889024274884(17)201130(10)2834589
• 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
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Study,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/06/2023

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: 11/30/2020
• Device Model Number: N/A
• Device Catalogue Number: 01.04212.465
• Device Lot Number: 2834589
• 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: 08/31/2023
• Initial Report FDA Received Date: 06/15/2023
• Supplement Report FDA Received Date: 09/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/03/2015
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10 NARRATIVE
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 60 YR
• Patient Sex: Male
• Patient Weight: 90 KG