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

Model Number N/A

Device Problem Human-Device Interface Problem (2949)

Patient Problems Pain (1994); Loss of Range of Motion (2032); Arthralgia (2355)

Event Date 04/18/2022

Event Type  Injury  

Event Description

It was reported that a patient underwent a revision surgery due to pain and lack of motion.Head and anchor were revised.Attempts have been made and no further information has been provided yet.

Manufacturer Narrative

Zimmer's reference (b)(4).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.Concomitant devices: cannulated drill with stop 6 mm, catalog: 47430706100; lot: 65092392; 2.5mm pin; catalog: 47430902501; lot: 65038433; 2.5mm drill; catalog:47430904601; lot: 65157512.Multiple mdr reports were filed for this event, please see associated reports: 0009613350-2022-00274.

Manufacturer Narrative

This follow-up report is being submitted to relay additional and/or corrected information.As neither the products nor any images of the products were received, visual and dimensional evaluations could not be performed.Review of the device history records identified no deviations or anomalies during manufacturing.The investigation did not identify a nonconformance or a complaint out of box (coob).The devices are used for treatment.Medical records were not provided.A definitive root cause related to the reported pain and lack of range of motion cannot be determined if an 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: EXTREMITIES 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: 14352130
• MDR Text Key: 291353957
• Report Number: 0009613350-2022-00275
• Device Sequence Number: 1
• Product Code: KWS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/30/2022

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 Model Number: N/A
• Device Catalogue Number: 01.04555.440
• Device Lot Number: 3043732
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/18/2022
• Initial Date FDA Received: 05/11/2022
• Supplement Dates Manufacturer Received: 04/04/2022
• Supplement Dates FDA Received: 08/31/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/17/2020
• 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): Required Intervention; Hospitalization
• Patient Weight: 104 KG