MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH DUROM US ACET CMPNT 56/50 P; DUROM ACETABULAR COMPONENT

Model Number N/A

Device Problems Appropriate Term/Code Not Available (3191); Migration (4003)

Patient Problems Pain (1994); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

The manufacturer did not receive devices or x-rays for review.Other source documents (surgical report) were provided.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.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.(b)(4).

Event Description

A product liability claim was raised.Patient was implanted on the right side and underwent revision surgery on an unknown date due to elevated cobalt and chromium levels.Patient also suffered from great pain post implantation.

Event Description

A product liability claim was raised.Patient was implanted on right side and underwent revision surgery due to pain and elevated metal ions, during revision surgery aseptic loosening of acetabular component was also observed.

Manufacturer Narrative

This follow-up report is being filled to relay additional information, which was unknown at the time of the previous medwatch.D10: medical products: versys hip system femoral stem; catalog #: 6578821430; lot#: 60055789.Metasul ldh, head, 50, code p, taper 18/20; catalog #: 01.00181.500; lot#: 2382496.Metasul ldh, head adapter, s, -4, taper 12/14-18/20; catalog #: 01.00185.145; lot#: 2365318.Therapy date: (b)(6) 2018.This case was reopened on (b)(6) 2021 to enter additional information which had been received on jul 1, 2021.Additionals: a2, a3, d4, d6, d10, g4, h3, h6, h10.Updates: b5, d1, d2.Corrections: b4, g3, g6, h2.Since this case is related to the issues for which zimmer implemented a notification in july 2008 as referenced above in h7 and h9, zimmer switzerland manufacturing gmbh will close this case once again.Zimmer¿s reference number of this file is (b)(4).

• Brand Name: DUROM US ACET CMPNT 56/50 P
• Type of Device: DUROM ACETABULAR COMPONENT
• Manufacturer (Section D): ZIMMER SWITZERLAND MANUFACTURING GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• MDR Report Key: 10904900
• MDR Text Key: 219169475
• Report Number: 0009613350-2020-00556
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• PMA/PMN Number: K053536
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Remedial Action: Notification
• Type of Report: Initial,Followup
• Report Date: 07/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/25/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/15/2012
• Device Model Number: N/A
• Device Catalogue Number: 01.00214.156
• Device Lot Number: 2392567
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: 9613350-07/15/2008-001C
• Patient Sequence Number: 1
• Treatment: SEE H10 NARRATIVE.
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 58 YR