MAUDE Adverse Event Report: ZIMMER GMBH DUROM; N/A

Model Number N/A

Device Problems Material Erosion (1214); Insufficient Information (3190)

Patient Problems Inflammation (1932); Pain (1994); Reaction (2414); No Information (3190)

Event Date 08/23/2019

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products and therapy date, detail of product: item number unknown, item name metasul ldh head, lot # unknown.Item number unknown, item name metasul ldh head adapter, lot # unknown.The manufacturer did not receive devices, x-rays, or other source documents for review, as the patient is currently being monitored and has not been revised to date.As no lot numbers were provided for the devices, the device history records could not be reviewed.The cause for this specific event cannot be ascertained from the information provided, as the patient has not been revised.The common clinical presentation and the date of the original implantation suggest that this case might be / is related to the issues for which zimmer implemented a notification in july 2008 as referenced above.Should additional information become available and / or the device(s) be returned for evaluation and an investigation result is available, an amended medical device report will be submitted.Therefore, zimmer (b)(4) considers this case as closed.(b)(4).

Event Description

A patient is pursuing a product liability claim following revision surgery due to unknown reasons.

Manufacturer Narrative

This follow-up report is being filled to relay additional information, which was unknown at the time of the previous medwatch.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

It was reported that patient underwent revision surgery due to pain, truninosis, periarticular inflammation, synovitis, metal wear debris with exaggerated biological reaction and rust colored joint effusion.

• Brand Name: DUROM
• Type of Device: N/A
• Manufacturer (Section D): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• MDR Report Key: 9813306
• MDR Text Key: 194922501
• Report Number: 0009613350-2020-00105
• 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: consumer
• Remedial Action: Notification
• Type of Report: Initial,Followup
• Report Date: 03/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2020
• 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: 03/12/2020
• 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; Required Intervention