• 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 DUROM, COMPONENT FOR ACETABULUM, UNCEMENTED, 58, 52, CODE R DUROM ACETABULAR COMPONENT AND METASUL LDH LARGE DIAMETER HEADS

  • 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 DUROM, COMPONENT FOR ACETABULUM, UNCEMENTED, 58, 52, CODE R DUROM ACETABULAR COMPONENT AND METASUL LDH LARGE DIAMETER HEADS Back to Search Results
Model Number N/A
Device Problem Biocompatibility (2886)
Patient Problem No Information (3190)
Event Date 09/22/2020
Event Type  Injury  
Manufacturer Narrative
Concomitant medical products: item# 01. 00181. 520, lot# 2394686, metasul ldh, head, 52, code r, taper 18/20. Review of event description: patient underwent revision due to metallosis. Other information & sources: review of the complaint relevant documents did not lead to new information regarding the reported event. No further due diligence required as all required information to support the conclusion is available/was already requested. Complex physiological reactions like pseudotumor or metal allergy are known risks for this kind of metal-on-metal implants as stated in zimmer¿s instruction leaflet for endoprothesis. Conclusion: no further investigation required as this issue is known and addressed in cp00000620 (error pattern: potential early revision of the acetabular component due to loosening, implant migration or unresolved pain, higher ion release). At least one of these error patterns is observed in this event. Should any additional information that changes the assessment become available to us, or any extra demand be requested, we will re-evaluate the case. Since this case is related to the issues for which zimmer implemented a notification in july 2008 as referenced above, zimmer gmbh will close this case. Zimmer biomet¿s reference number of this file is (b)(4).
 
Event Description
It was reported that a patient underwent revision surgery due to metallosis. Attempts to obtain additional information have been made; however, no more is available.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameMETASUL DUROM, COMPONENT FOR ACETABULUM, UNCEMENTED, 58, 52, CODE R
Type of DeviceDUROM 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 Key10769572
MDR Text Key214127210
Report Number0009613350-2020-00519
Device Sequence Number1
Product Code KWA
Combination Product (y/n)N
Reporter Country CodeIT
PMA/PMN Number
K053536
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Reporter Occupation
Remedial Action Notification
Type of Report Initial,Followup
Report Date 11/25/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/02/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/30/2012
Device Model NumberN/A
Device Catalogue Number01.00214.058
Device Lot Number2396164
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 Received10/28/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/25/2007
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Invalid Data
Removal/Correction NumberN/A

Patient Treatment Data
Date Received: 11/02/2020 Patient Sequence Number: 1
-
-