Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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.
 
Manufacturer Narrative
This follow up report is being filled to relay additional information, which was unknown at the time of the initial report.New information received: lot number.Name and address of implantation hospital.Revision date : (b)(6) 2020.New information does not change the investigation-results of this incident, an additional report will be submitted when additional information becomes available.The need for corrective measures is not indicated and zimmer switzerland manufacturing gmbh considers this case as closed.Zimmer biomet's reference number of this file is (b)(4).
 
Event Description
This follow up report is being filled to relay additional information, which was unknown at the time of the initial report.New information received: lot number.Name and address of implantation hospital.Revision date : (b)(6) 2020.New information does not change the investigation-results of this incident, an additional report will be submitted when additional information becomes available.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
METASUL DUROM, COMPONENT FOR ACETABULUM, UNCEMENTED, 58, 52, CODE R
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
MDR Report Key10769572
MDR Text Key214127210
Report Number0009613350-2020-00519
Device Sequence Number1
Product Code KWA
Combination Product (y/n)N
PMA/PMN Number
K053536
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
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
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Expiration Date06/30/2012
Device Model NumberN/A
Device Catalogue Number01.00214.058
Device Lot Number2396164
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 10/05/2020
Initial Date FDA Received11/02/2020
Supplement Dates Manufacturer Received10/28/2020
Supplement Dates FDA Received11/25/2020
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A
Patient Sequence Number1
Treatment
SEE H10
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age67 YR
-
-