MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH SIDUS® STEM-FREE SHOULDER, HUMERAL HEAD, 46-16; SHOULDER PROSTHESIS

Model Number N/A

Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problems Failure of Implant (1924); Pain (1994); Joint Dislocation (2374)

Event Date 07/03/2023

Event Type  Injury  

Event Description

It was reported that patient with total shoulder prosthesis has been revised four (4) years after initial surgery due to pain, liner fracture and dislocation.Attempts have been made and no further information has been provided.

Manufacturer Narrative

(b)(4).G2: foreign: switzerland.D10: associated products: item reference:01.04440.013, item name:anaverse¿ glenoid, liner, m, humeral head, 46-16, item lot:2977500.Item reference:01.04440.033, item name:dpsc screw, 33mm 46-16, item lot:2994817.Item reference:01.04440.036, item name:dpsc screw, 36mm, 46-16, item lot:2994818.Item reference:01.04555.120, item name:sidusâ® stem-free shoulder, humeral anchor, uncemented, m, 46-16, item lot:2960619.Item reference:01.04440.003, item name:anaverse¿ glenoid, baseplate, m, 15mm, 46-16, item lot:2994240.Investigation of this incident is currently ongoing.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.

Event Description

Upon review of this complaint from an investigation perspective, it is now considered that the sidus® stem-free shoulder, humeral head, within this complaint does not impact the reported event of liner fracture and dislocation.Hence this report will be voided.

Manufacturer Narrative

(b)(4).Upon review of this complaint from an investigation perspective, it is now considered that the sidus® stem-free shoulder, humeral head, within this complaint does not impact the reported event of liner fracture and dislocation.Given the above information this medwatch will be voided.

• Brand Name: SIDUS® STEM-FREE SHOULDER, HUMERAL HEAD, 46-16
• Type of Device: 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: 17441502
• MDR Text Key: 320202776
• Report Number: 0009613350-2023-00432
• Device Sequence Number: 1
• Product Code: HSD
• UDI-Device Identifier: 00889024415942
• UDI-Public: (01)00889024415942(17)290131(10)2980304
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K171858
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/14/2023

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
• Device Operator: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: 01.04555.460
• Device Lot Number: 2980304
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/26/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/10/2023
• Initial Date FDA Received: 08/02/2023
• Supplement Dates Manufacturer Received: 09/08/2023
• Supplement Dates FDA Received: 09/14/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/14/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Male