• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH METASUL LDH, HEAD, 48, CODE N, TAPER 18/20 HIP PROSTHESIS

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

ZIMMER SWITZERLAND MANUFACTURING GMBH METASUL LDH, HEAD, 48, CODE N, TAPER 18/20 HIP PROSTHESIS Back to Search Results
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: durom us acet cmpnt 54/48 n; catalog#: 01. 00214. 154; lot#: 2423579, 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. 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.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameMETASUL LDH, HEAD, 48, CODE N, TAPER 18/20
Type of DeviceHIP PROSTHESIS
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 Key12307055
MDR Text Key266154060
Report Number0009613350-2021-00389
Device Sequence Number1
Product Code KWA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
N/A
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
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
Date FDA Received08/11/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date11/15/2012
Device Model NumberN/A
Device Catalogue Number01.00181.480
Device Lot Number2426404
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received07/26/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/28/2007
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction Number9613350-07/15/2008-001C

Patient Treatment Data
Date Received: 08/11/2021 Patient Sequence Number: 1
-
-