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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH DURASUL, ALPHA INSERT, II/36 N/A

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ZIMMER SWITZERLAND MANUFACTURING GMBH DURASUL, ALPHA INSERT, II/36 N/A Back to Search Results
Model Number N/A
Device Problems Fitting Problem (2183); Device-Device Incompatibility (2919)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/01/2021
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: durasul, alpha insert, ii/36; item# 0100013709; lot# 3046062. Allofit alloclassic, shell with polar screw plug, uncemented, 52/ii; item# 4245; lot# 3038703. The manufacturer received x-rays and other source documents for review. The manufacturer did not receive yet the device, however it is indicated by complainant that it will be returned for investigation. The device history records were reviewed and found to be conforming. Additional information has been requested and is currently not available. A cause for this specific event cannot be ascertained from the information provided. As soon as supplemental information becomes available an updated report will be submitted. (b)(4).
 
Event Description
During the surgery, the surgeon tried to replace the liner twice with a new one but could not do so to the same cup. Hence, the surgeon revised the cup with a new allofit shell and used a new durasul liner. There was a surgical delay of about 15 minutes.
 
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Brand NameDURASUL, ALPHA INSERT, II/36
Type of DeviceN/A
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 Key11337384
MDR Text Key233568790
Report Number0009613350-2021-00078
Device Sequence Number1
Product Code KWY
Combination Product (y/n)N
Reporter Country CodeNL
PMA/PMN Number
N/A
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/17/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/17/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue Number01.00013.709
Device Lot Number3043864
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/11/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received06/14/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/23/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberN/A

Patient Treatment Data
Date Received: 02/17/2021 Patient Sequence Number: 1
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