MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH DUROM US ACET CMPNT 54/48 N; DUROM ACETABULAR COMPONENT AND METASUL LDH LARGE DIAMETER HEADS

Model Number N/A

Device Problems Corroded (1131); Material Erosion (1214); Biocompatibility (2886)

Patient Problems Foreign Body Reaction (1868); Pain (1994); Local Reaction (2035); Metal Related Pathology (4530)

Event Date 05/16/2019

Event Type  Injury  

Manufacturer Narrative

This product is manufactured by zimmer biomet (b)(4) and is not cleared or distributed in the u.S.However, this report is being submitted as zimmer biomet (b)(4) manufactures a similar device that is cleared or distributed in the united states.Concomitant medical products: metasul ldh, head, 48, code n, taper 18/20; catalog#: 01.00181.480; lot#: 2426404 metasul ldh, head adapter, s, -4, taper 12/14-18/20; catalog#: 01.00185.145; lot#: 2421995 femoral stem press-fit collarless 12/14 neck taper standard body extended neck offset size 14 149 mm stem length cementless; catalog#: 00-7864-014-20; lot#: 60892889.Therapy date: (b)(6) 2019.The manufacturer received x-rays and other source documents for review.Where lot numbers were received for the devices, the device history records were reviewed and found to be conforming.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.Therefore, zimmer (b)(4) considers this case as closed.Zimmers reference number of this file is (b)(4).

Event Description

Patient was implanted with a durom cup on the left side and underwent a revision surgery due to pain, metallosis, elevated metal ion levels, decreased activity of daily living, corrosion and adverse local tissue reaction.

• Brand Name: DUROM US ACET CMPNT 54/48 N
• Type of Device: DUROM ACETABULAR COMPONENT AND METASUL LDH LARGE DIAMETER HEADS
• Manufacturer (Section D): ZIMMER SWITZERLAND MANUFACTURING GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer (Section G): ZIMMER SWITZERLAND MANUFACTURING 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: 12307048
• MDR Text Key: 266002267
• Report Number: 0009613350-2021-00388
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K053536
• 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: 08/11/2021

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 Expiration Date: 12/15/2012
• Device Model Number: N/A
• Device Catalogue Number: 01.00214.154
• Device Lot Number: 2423579
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/26/2021
• Initial Date FDA Received: 08/11/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/14/2007
• 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
• Patient Age: 75 YR
• Patient Weight: 95