MAUDE Adverse Event Report: ZIMMER GMBH SIDUS STEM-FREE SHOULDER, HUMERAL ANCHOR, UNCEMENTED, S; SIDUS EXTREMITIES IMPL WIN GEN

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problem No Code Available (3191)

Event Date 12/27/2017

Event Type  Injury  

Manufacturer Narrative

Concomitant medical product: sidus extremities impl win gen; part# unknown; lot# unknown.Therapy date: (b)(6) 2017.The manufacturer did not receive x-rays, or other source documents for review.The manufacturer did not receive the device for investigation.As no lot number was provided, the device history records could not be reviewed.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.(b)(4).

Event Description

Patient was implanted on an unknown side and underwent revision surgery as the implant was not working as intended.

Manufacturer Narrative

Additionl information has been received.D11, concomitant medical device: sidus stem-free shoulder, humeral head, 42-15, ref#: (b)(4), lot#2648103.Where lot numbers were received for the device, the device history records were reviewed and found to be conforming.The following reports are associated to this event: 0009613350-2018-01190.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 now reported that the implants were removed due to revision to reverse shoulder.Device is not broken.A rotator cuff failure occurred and therefore a revision to reverse shoulder was performed.

Manufacturer Narrative

This follow-up report is being filled to relay investigation result.Additional and corrected information are filled in the following fields: dhr review: the device manufacturing quality records indicate that the released components met all requirements to perform as intended.Trend analysis: no trend considering the following event is identified: revision due to failed rotator cuff treatment event description: it was reported that in a 79-year-old female patient the sidus anchor and head implanted on (b)(6) 2013 were revised to a reverse shoulder on (b)(6) 2017 due to rotator cuff failure.The patient took place in the sidus pmcf study (protocol id: cme2012-01e).Review of received data: no medical data such as x-rays, surgical notes or any other case-relevant documents received.Device analysis: no product was returned to zimmer biomet for investigation.Review of product documentation: the product combination was approved by zimmer biomet.Conclusion: it was reported that in a 79-year-old female patient the sidus anchor and head implanted on (b)(6) 2013 were revised to a reverse shoulder on (b)(6) 2017 due to rotator cuff failure.Neither the retrievals, medical documentation such as x-rays, surgical notes or study notes have been received.In addition, the event description is insufficient.The quality records of the sidus anchor and the sidus head show that all specified characteristics (material, dimensions, surface, etc.) have met the specifications valid at the time of production.As it was reported that the patient had a rotator cuff tear, the involvement of the sidus implants on the decision to revise the system to a reverse shoulder is unknown.Overall, based on significant lack of information, we were not able to perform an in-depth investigation 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).

Event Description

Please refer to report.

• Brand Name: SIDUS STEM-FREE SHOULDER, HUMERAL ANCHOR, UNCEMENTED, S
• Type of Device: SIDUS EXTREMITIES IMPL WIN GEN
• Manufacturer (Section D): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• MDR Report Key: 7982875
• MDR Text Key: 124290789
• Report Number: 0009613350-2018-01084
• Device Sequence Number: 1
• Product Code: PKC
• Combination Product (y/n): N
• PMA/PMN Number: PN/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,s
• Type of Report: Initial,Followup,Followup
• Report Date: 03/29/2019

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: 02/28/2022
• Device Model Number: N/A
• Device Catalogue Number: 01.04555.110
• Device Lot Number: 2643707
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/28/2018
• Initial Date FDA Received: 10/19/2018
• Supplement Dates Manufacturer Received: 11/16/2018; 03/27/2019
• Supplement Dates FDA Received: 12/06/2018; 03/29/2019
• 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: 72 YR
• Patient Weight: 75