MAUDE Adverse Event Report: ZIMMER GMBH DUROM ACETABULAR COMPONENT

Model Number N/A

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Fatigue (1849); Memory Loss/Impairment (1958); Swelling (2091); Sleep Dysfunction (2517)

Event Date 02/12/2016

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: m/l taper stem hip impl win gen; catalog no#: unknown; lot#: unknown.Durom head hip impl win gen; catalog no#: unknown; lot#: unknown.Therapy date: (b)(6) 2017.The manufacturer did not receive devices or x-rays 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 as referenced above.Should additional information become available and / or the device(s) be returned for evaluation and an investigation result be available, that changes this assessment, an amended medical device report will be submitted.(b)(4).

Event Description

Patient was implanted on left side and underwent revision due to elevated metal ion levels, metallosis, pseudotumor, obstruction in walking.

• 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
• Manufacturer (Section G): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 9731329
• MDR Text Key: 188638569
• Report Number: 0009613350-2020-00074
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Remedial Action: Notification
• Type of Report: Initial
• Report Date: 02/20/2020

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
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/07/2020
• Initial Date FDA Received: 02/20/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: 9613350-07/15/2008-001C
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention