MAUDE Adverse Event Report: ZIMMER BIOMET GMBH SWITZERLAND SIDUS STEM-FREE SHOULDER, HUMERAL HEAD, 44-16; PROSTHESIS, TOTAL ANATOMIC SHOULDER

Model Number N/A

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Pain (1994); Metal Related Pathology (4530); Unspecified Tissue Injury (4559)

Event Date 08/26/2022

Event Type  Injury  

Event Description

It was reported that the patient experienced pain about 9 years post initial hemi arthroplasty.Rotator cuff tear was confirmed on ct scan and revision surgery took place.During removal of the implants, it was noted there was metallosis and anchor had worn and disformed.Due diligence is in progress.

Manufacturer Narrative

(b)(4).Report source-foreign.Concomitant medical products:-sidus stem-free shoulder, humeral head, 44-16,lot#2685032 item#0104555440.Multiple mdr reports were filed for this event, please see associated reports: 0009613350-2022-00454.Investigation of this incident is currently ongoing.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.

Manufacturer Narrative

(b)(4).The following sections were updated: b4, b5, d9, g3, g6, h1, h2, h3, h6, h10.This follow-up report is being submitted to relay additional and/or corrected information.No products were returned.Visual examination of the provided information showed that the humeral anchor is fractured and pieces are missing.However, based on the investigation it is not possible to conclude if the damage occurred during time in vivo and if that may have contributed to the reported metallosis.Review of the device history records identified no deviations or anomalies during manufacturing.Devices are used for treatment.One radiograph was provided but was not reviewed by a health care professional as image on humeral anchors was unclear.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 Description

No further event information available at the time of this report.

• Brand Name: SIDUS STEM-FREE SHOULDER, HUMERAL HEAD, 44-16
• Type of Device: PROSTHESIS, TOTAL ANATOMIC SHOULDER
• Manufacturer (Section D): ZIMMER BIOMET GMBH SWITZERLAND; 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: 15409634
• MDR Text Key: 299762396
• Report Number: 0009613350-2022-00455
• Device Sequence Number: 1
• Product Code: PKC
• UDI-Device Identifier: 00889024415935
• UDI-Public: (01)00889024415935(17)221130(10)2685032
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 02/13/2023

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: Health Professional
• Device Expiration Date: 11/30/2022
• Device Model Number: N/A
• Device Catalogue Number: 01.04555.440
• Device Lot Number: 2685032
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/26/2022
• Initial Date FDA Received: 09/13/2022
• Supplement Dates Manufacturer Received: 01/18/2022
• Supplement Dates FDA Received: 02/13/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/04/2012
• 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
• Treatment: SEEH10 NARRATIVE
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Sex: Prefer Not To Disclose