MAUDE Adverse Event Report: ZIMMER GMBH SIDUS

Model Number N/A

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Erosion (1750)

Event Date 11/05/2019

Event Type  Injury  

Manufacturer Narrative

The manufacturer did not receive x-rays 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.Zimmer biomet¿s reference number of this file is (b)(4).

Event Description

Patient was implanted on an unknown side and underwent revision surgery due to bone loss/erosion.

Event Description

Please refer to report 0009613350-2020-00006.

Manufacturer Narrative

This follow-up report is being filled to relay investigation result.Dhr review: the device manufacturing quality records indicate that the released components met all requirements to perform as intended.Trend analysis: due to lack of information it's not possible to make meaningful trend.Event description: it was reported that the patient was implanted with sidus implant on an unknown date.Patient underwent revision due to bone loss/erosion.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 in-depth analysis.Review of product documentation: - this device is intended for treatment.- the compatibility check could not be performed as there is no item# reported.- dhr review could not be performed since no lot number was available.Conclusion: - part and lot identification are necessary for review of device history records, neither were provided.- no product was returned or pictures provided; visual and dimensional evaluations could not be performed.- this device is used for treatment.- insufficient information provided.Unable to perform a compatibility check.- medical records were not provided.- root cause could not be determined.- no corrective actions, preventive actions, or field actions resulted after investigation of this event.It was reported that the patient was implanted with sidus implant on an unknown date.Patient underwent revision due to bone loss/erosion(osteolysis).In vivo time of the device is unknown.The investigation results did not identify a non-conformance or a complaint out of box (coob).However, based on the available information, we were not able to identify an exact root cause for this issue.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).

• Brand Name: SIDUS
• Type of Device: SIDUS
• Manufacturer (Section D): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• MDR Report Key: 9552207
• MDR Text Key: 174871558
• Report Number: 0009613350-2020-00006
• Device Sequence Number: 1
• Product Code: PKC
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 02/18/2020

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: 12/12/2019
• Initial Date FDA Received: 01/06/2020
• Supplement Dates Manufacturer Received: 02/11/2020
• Supplement Dates FDA Received: 02/18/2020
• 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