MAUDE Adverse Event Report: ZIMMER GMBH SIDUS STEM-FREE SHOULDER, HUMERAL HEAD, 44-16

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problem No Information (3190)

Event Date 12/12/2018

Event Type  Injury  

Manufacturer Narrative

Device product code: pkc.Medical products and therapy date detail of product: item # 0104555120, item name sidus stem-free shoulder, humeral anchor, uncemented, m lot # 2707104.The manufacturer did not receive x-rays, or other source documents for review.The manufacturer did not receive the device for investigation.The device history records were reviewed and found to be conforming.Attempts to obtain additional information have been made; however, no more is available.A cause for this specific event cannot be ascertained from the information provided.As soon as supplemental information becomes available, an updated report will be submitted.Zimmer biomet¿s reference number of this file is (b)(4).

Event Description

It was reported that patient underwent revision surgery due to unknown reason.

Event Description

It was now reported that there is a study for this case: "sidus stem-free shoulder study" (b)(6).It was reported that patient underwent revision surgery due to unknown reason.

Manufacturer Narrative

This follow-up report is being filled to relay additional information, which was unknown at the time of initial medwatch.New information received: - clinical study.Corrected and additional information is filled in the follwing fields: additional: g5, h2.Correction: b4, b5, g4, g7, h10.Investigation of this incident is currently ongoing, a follow up report will be submitted when additional information becomes available.Zimmer biomet¿s reference number of this file is (b)(4).

Manufacturer Narrative

Trend analysis: no trend has been indentified.Event description: it was reported that a sidus implant was implanted on (b)(6) 2013 and revised on (b)(6) 2018 due to unknown reasons.Review of received data: no medical data such as x-rays, surgical notes or any other case-relevant documents received.Devices analysis: no product was returned to zimmer biomet for in-depth analysis.Review of product documentation: these device are intended for treatment.Conclusion summary: the investigation results did not identify a non-conformance or a complaint out of box (coob).Nature of the event remains unknown.Neither x-rays, pictures of the explants nor any other medical documents were received; therefore the condition of the component is unknown.Patient factors that may affect the performance of the components such as bone quality, activity level, type of activity (low impact vs.High impact), and relevant medical history are unknown.In conclusion, due to significant lack of information, it is impossible to perform a meaningful analysis of the reported event.Therefore, an exact root cause cannot be determined.The need for corrective measures is not indicated and zimmer gmbh considers this case as closed.Zimmer biomet's reference number of this file is (b)(4).The following reports are associated with this event: 0009613350 - 2019 - 00504 - 2.

Event Description

Investigation results are now available.

• Brand Name: SIDUS STEM-FREE SHOULDER, HUMERAL HEAD, 44-16
• Type of Device: SIDUS STEM-FREE SHOULDER
• Manufacturer (Section D): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• MDR Report Key: 8904895
• MDR Text Key: 154703790
• Report Number: 0009613350-2019-00503
• Device Sequence Number: 1
• Product Code: PKC
• UDI-Device Identifier: 00889024415935
• UDI-Public: 00889024415935
• Combination Product (y/n): N
• PMA/PMN Number: K171858
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 04/27/2020

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 Expiration Date: 02/28/2023
• Device Model Number: N/A
• Device Catalogue Number: 01.04555.440
• Device Lot Number: 2700911
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/07/2019
• Initial Date FDA Received: 08/19/2019
• Supplement Dates Manufacturer Received: 09/06/2019; 04/03/2020
• Supplement Dates FDA Received: 10/03/2019; 04/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 67 YR
• Patient Weight: 90