MAUDE Adverse Event Report: ZIMMER GMBH SIDUS HEAD EXTREMITIES; N/A

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problem Limited Mobility Of The Implanted Joint (2671)

Event Date 05/21/2019

Event Type  Injury  

Manufacturer Narrative

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.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).Split case, (b)(4).Item and lot numbers unknown.

Event Description

It was reported that following mobility problem, patient underwent revision surgery.The head was replaced and a glenoid component was added.

Event Description

It was additionally reported that the patient developed glenoidite and capsulite due to absence of glenoid implant.

Manufacturer Narrative

X-rays were received and will be reviewed within investigation.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).

Manufacturer Narrative

This follow-up report is being filled to relay investigation result.Dhr review: as no lot number was provided, the device history records could not be reviewed.Trend analysis: a complaint history review, including part and lot specific investigation, could not be performed as the item number is unknown.Event description: it was reported that the patient had a sidus prosthesis implanted on an unknown date and revised on the (b)(6) 2019 due to mobility issues (glenoiditis, capsulitis) of the patient's shoulder and the surgeon needing to remove the head so that there is enough space to implant a glenoid component.Review of received data: no medical data such as x-rays, surgical notes or any other case-relevant documents received.An x-ray image was received post revision surgery, which is however not relevant to the reported event.Device analysis: no product was returned to zimmer biomet for in-depth analysis.Review of product documentation: all reported devices are intended for treatment.The compatibility check was performed and showed that the product combination was approved by zimmer biomet.Conclusion: it was reported that the patient had a sidus prosthesis implanted on an unknown date and revised on the (b)(6) 2019 due to mobility issues (glenoiditis, capsulitis) of the patient's shoulder and the surgeon needing to remove the head so that there is enough space to implant a glenoid component.The investigation results did / did not identify a non-conformance or a complaint out of box (coob).Neither x-rays of the reported component in-vivo, operative notes, office visit notes, nor devices or photos of the explanted implant 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.Adherence to rehabilitation protocol is unknown.Erosion of the bony glenoid is a known complication of shoulder hemiarthroplasty.However, the implantation date, respectively the time in-vivo, of the device is not known.No product identification has been provided, making an estimation of time in-vivo on the basis of the maufacturing date not possible.The activity level of the patient as well as further patient info is not known, which could have contributed to glenoid erosion.No event of any trauma is known.The sidus prosthesis (humeral head) was also noted as being revised as a consequence of the surgeon needing additional space in order to implant a glenoid component.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).

Event Description

Please refer to report 0009613350-2019-00552.

• Brand Name: SIDUS HEAD EXTREMITIES
• Type of Device: N/A
• Manufacturer (Section D): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• MDR Report Key: 8963992
• MDR Text Key: 156570389
• Report Number: 0009613350-2019-00552
• Device Sequence Number: 1
• Product Code: PKC
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• 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: 04/03/2020

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 Model Number: N/A
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/29/2019
• Initial Date FDA Received: 09/05/2019
• Supplement Dates Manufacturer Received: 09/12/2019; 04/03/2020
• Supplement Dates FDA Received: 09/18/2019; 04/03/2020
• 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