MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH ANATOMICAL SHOULDER DOMELOCK, HUMERAL HEAD, 44-16, R=24.4MM; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Model Number	01.04212.445
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Loss of Range of Motion (2032); Scar Tissue (2060); Subluxation (4525)
Date of Event	02/16/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported through a clinical study that a patient underwent an initial right total shoulder arthroplasty approximately six (6) years ago.Approximately seven (7) months after implantation, the patient had developed pain.About one and half (1,5) years later, infection was ruled out and components were found to be stable, however extensive debridement of intra-and extra-articular scar tissue was required.As of the five (5) year study follow-up visit, the patient is satisfied and able to complete the majority of daily activities with minimal pain.There have been no other adverse events or complications reported.The original study components remain implanted.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
(b)(4).D10: item#: 01.04227.005; lot#: 2885046; item name: anatomical shoulder, anatomical shoulder domelock, dome, centric.Item#: 01.04201.123; lot#: 2894588; item name: anatomical shoulder, humeral stem, uncemented, 12, 100 mm.Item#: 01.04214.340; lot#: 2852772; item name: anatomical shoulder, glenoid, pegged, cemented, s.G2-foreign: switzerland.Multiple mdr reports were filed for this event, please see associated reports: 0009613350 -2023 -00258, 0009613350 -2023 -00259, 0009613350 -2023 -00261.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.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional and/or corrected information.No products were 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.Six radiographic images of the right shoulder were provided and assessed with the following assessment: right shoulder arthroplasty components are anatomically aligned.There is no abnormality.Alignment is maintained with minimal anterior position of the humeral head in relation to the glenoid.Alignment is maintained without interval change.The following impressions were additionally provided: anatomic alignment of the right shoulder arthroplasty with minimal anterior position of the humeral head in relation to the glenoid on the radiographs.The humeral head implant does not appear too large (overstuffed).Bone quality appears mildly osteopenic on all images.Based on the given information and the results of the investigation, a definitive root cause cannot be determined.Multiple mdr reports were filed for this event, please see associated reports: 0009613350-2023-00258-1, 0009613350-2023-00259-1, 0009613350-2023-00261-1.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 through a clinical study that a patient underwent an initial right total shoulder arthroplasty approximately six (6) years ago.Approximately seven (7) months after implantation, the patient had developed pain.About one and half (1,5) years later, infection was ruled out and components were found to be stable, however extensive debridement of intra-and extra-articular scar tissue was required.The head was noted to be slightly overstuffed and somewhat subluxated ventrally.As of the five (5) year study follow-up visit, the patient is satisfied and able to complete the majority of daily activities with minimal pain.There have been no other adverse events or complications reported.The original study components remain implanted.Attempts have been made and no further information has been provided.

• Brand Name: ANATOMICAL SHOULDER DOMELOCK, HUMERAL HEAD, 44-16, R=24.4MM
• 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: 17115123
• Report Number: 0009613350-2023-00260
• Device Sequence Number: 6612011
• Product Code: HSD
• UDI-Device Identifier: 00889024480353
• UDI-Public: (01)00889024480353(17)210331(10)2851157
• 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: 2017
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/09/2023

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: 03/31/2021
• Device Model Number: 01.04212.445
• Device Catalogue Number: 01.04212.445
• Device Lot Number: 2851157
• 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: 05/16/2023
• Supplement Date Received by Manufacturer: 07/21/2023
• Initial Report FDA Received Date: 06/13/2023
• Supplement Report FDA Received Date: 08/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/10/2016
• 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 Sex: Female
• Patient Weight: 97 KG