MAUDE Adverse Event Report: ZIMMER GMBH DUROM ACETABULAR COMPONENT

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problem No Code Available (3191)

Event Date 01/12/2014

Event Type  Injury  

Manufacturer Narrative

The manufacturer did not receive devices, x-rays, or other source documents for review.As no lot numbers were provided for the devices, the device history records could not be reviewed.While a cause for this specific event cannot be ascertained from the information provided, the common clinical presentation and the date of the original implantation suggest that this case is related to the issues for which zimmer implemented a notification in july 2008.Should additional information become available and / or the device(s) be returned for evaluation and an investigation result becomes available, that changes this assessment, an amended medical device report will be submitted.The need for further corrective measures is not indicated at this time.Zimmer¿s reference number of this file is (b)(4).

Event Description

Patient was implanted on the right side and is being monitored due to elevated metal ions.

Event Description

No change to previously reported event.

Manufacturer Narrative

This follow-up report is being submitted to relay corrected and additional information.Review of event description: the patient experienced elevated metal ion levels.Other information & sources (if applicable): review of the complaint relevant documents did not lead to new information regarding the reported event.Dhr review: n/a the dhr check could not be performed as the lot number was not available.No further due diligence required as all required information to support the conclusion is available/was already requested.Complex physiological reactions like pseudotumor or metal allergy are known risks for this kind of metal-on-metal implants as stated in zimmer¿s instruction leaflet for endoprothesis.Conclusion: no further investigation required as this issue is known and addressed in (b)(4) (error pattern: potential early revision of the acetabular component due to loosening, implant migration or unresolved pain, higher ion release).At least one of these error patterns is observed in this event.Since this case is related to the issues for which zimmer implemented a notification in july 2008 as referenced above, zimmer gmbh will close this case once again.Zimmer biomet¿s reference number of this file is (b)(4).

• Brand Name: DUROM ACETABULAR COMPONENT
• Type of Device: DUROM ACETABULAR COMPONENT
• Manufacturer (Section D): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• MDR Report Key: 9853449
• MDR Text Key: 194319637
• Report Number: 0009613350-2020-00141
• Device Sequence Number: 1
• Product Code: KXA
• 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: other
• Remedial Action: Notification
• Type of Report: Initial,Followup
• Report Date: 07/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2020
• 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
• Date Manufacturer Received: 07/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: 9613350-07/15/2008-001C
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization