MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH SIDUS GLENOID EXTREMITIES; EXTREMITIES PROSTHESIS

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problems No Information (3190); Insufficient Information (4580)

Event Type  Injury  

Manufacturer Narrative

The manufacturer received other source documents for review.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 date.A revision surgery is planned due to unknown reasons.Surgeon has requested for a revision procedure with the vrs glenoid if it is wear less.

Manufacturer Narrative

Event description: it was reported that a scan had been sent to the pmi department for potential plan to revise a right sidus implant currently implanted in the patient.Subsequently, the surgeon informed us that a pmi is no longer the plan and they have not made further plans.The initial surgery occurred in another hospital and therefore no further information is available on the sidus implantation.Review of received data: due diligence: no further due diligence required as all required information to support the conclusion is available or was already requested.No medical data relevant to the case has been received.Product evaluation: the product remains implanted.Review of product documentation: device purpose: this device is intended for treatment.Product compatibility: the compatibility check could not be performed due to missing product identification.Dhr review: review of the device history records could not be performed due to missing product identification.Conclusion: it was reported that a scan had been sent to the pmi department for potential plan to revise a right sidus implant currently implanted in the patient.Subsequently, the surgeon informed us that a pmi is no longer the plan and they have not made further plans.The initial surgery occurred in another hospital and therefore no further information is available on the sidus implantation.No product information has been received, therefore, review of the quality records was not possible.Due to significant lack of information a detailed investigation could not be performed, nevertheless as the product remained implanted there is no indication of a nonconformance or complaint out of box (coob).Based on the unknown event details, the complaint could not be confirmed.The need for corrective measures is not indicated and zimmer switzerland manufacturing gmbh considers this case as closed.Zimmer biomet's reference number of this file is (b)(4).

Event Description

Investigation has been completed.

• Brand Name: SIDUS GLENOID EXTREMITIES
• Type of Device: EXTREMITIES PROSTHESIS
• Manufacturer (Section D): ZIMMER SWITZERLAND MANUFACTURING GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• MDR Report Key: 11186232
• MDR Text Key: 227486421
• Report Number: 0009613350-2021-00020
• 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
• Report Date: 08/06/2021

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: 01/05/2021
• Initial Date FDA Received: 01/18/2021
• Supplement Dates Manufacturer Received: 07/07/2021
• Supplement Dates FDA Received: 08/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 65 YR