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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 HIP PROSTHESIS

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ZIMMER SWITZERLAND MANUFACTURING GMBH DURASUL, ALPHA INSERT, II/36 HIP PROSTHESIS Back to Search Results
Model Number N/A
Device Problems Device Dislodged or Dislocated (2923); Naturally Worn (2988)
Patient Problems Subluxation (4525); Metal Related Pathology (4530)
Event Date 02/01/2021
Event Type  Injury  
Manufacturer Narrative
This product is manufactured by zimmer biomet winterthur and is not cleared or distributed in the u. S. However, this report is being submitted as zimmer biomet winterthur manufactures a similar device that is cleared or distributed in the united states. Medical products: allofit alloclassic, shell with polar screw plug, uncemented, 52/ii; catalog#: 4245; lot#: 3038703. Therapy date: (b)(6) 2021. The manufacturer received x-rays and other source of documents for review. The manufacturer did not receive the device for investigation. Where lot numbers were received for the devices, the device history records were reviewed and found to be conforming. 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. Zimmer biomet¿s reference number of this file is (b)(4).
 
Event Description
Patient received primary tha on an unknown side and underwent a revision surgery due to dislocation and liner wear. During the surgery metallosis was observed, the surgeon also reported that the liner was not fixed into the shell. This is patient's second revision surgery.
 
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Brand NameDURASUL, ALPHA INSERT, II/36
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 Key11337359
MDR Text Key235046758
Report Number0009613350-2021-00074
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? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue Number01.00013.709
Device Lot Number3028069
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/03/2021
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 Manufactured04/02/2020
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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