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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH METASUL HEAD 28MM "S" 12/14 HIP PROSTHESIS

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ZIMMER SWITZERLAND MANUFACTURING GMBH METASUL HEAD 28MM "S" 12/14 HIP PROSTHESIS Back to Search Results
Model Number N/A
Device Problems Biocompatibility (2886); Insufficient Information (3190)
Patient Problems Metal Related Pathology (4530); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 01/15/2021
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: metasul, alpha insert, gg/28; catalog#: 01. 00010. 407; lot#: 2220524; fitmore, shell with screw cones, uncemented, 48/gg; catalog#: 01. 00024. 548; lot#: 2213918; vite spon. Tit. Diam. 6,5x30; catalog#: 02. 06000. 030; lot#: 040104d; vite spon. Tit. Diam. 6,5x25, gg/28; catalog#: 02. 06000. 025; lot#: 040111c. Therapy date: (b)(6) 2021. The manufacturer received other source document 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 was implanted on an unknown side and underwent a revision surgery due to metallosis.
 
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Brand NameMETASUL HEAD 28MM "S" 12/14
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 Key11337386
MDR Text Key232340223
Report Number0009613350-2021-00072
Device Sequence Number1
Product Code KWA
Combination Product (y/n)N
Reporter Country CodeIT
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 08/11/2021
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 Expiration Date02/15/2009
Device Model NumberN/A
Device Catalogue Number19.28.05
Device Lot Number2207154
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 Received07/14/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/04/2004
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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