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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH DUROM US ACET CMPNT 58/52 R DUROM ACETABULAR COMPONENT AND METASUL LDH LARGE DIAMETER HEADS

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ZIMMER SWITZERLAND MANUFACTURING GMBH DUROM US ACET CMPNT 58/52 R DUROM ACETABULAR COMPONENT AND METASUL LDH LARGE DIAMETER HEADS Back to Search Results
Model Number N/A
Device Problem Insufficient Information (3190)
Patient Problems Cyst(s) (1800); Foreign Body Reaction (1868); Pain (1994); Local Reaction (2035); Metal Related Pathology (4530)
Event Date 03/12/2021
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: metasul ldh, head, 52, code r, taper 18/20; catalog#: 01. 00181. 520; lot#: 2420752 metasul ldh, head adapter, m, 0, taper 12/14-18/20; catalog#: 01. 00185. 146; lot#: 2424840. Therapy date: (b)(6) 2021. The manufacturer did not receive devices or other source documents for review. X-rays were received and will be reviewed. Where lot numbers were received for the devices, the device history records were reviewed and found to be conforming. While a cause for this specific event cannot be ascertained from the information provided, the common clinical presentation and the date of the original implantation suggest that this case is related to the issues for which zimmer implemented a notification in july 2008. Should additional information become available and / or the device(s) be returned for evaluation and an investigation result becomes available, that changes this assessment, an amended medical device report will be submitted. The need for further corrective measures is not indicated at this time. (b)(4).
 
Event Description
Patient was implanted on the right side and underwent a revision surgery due to pain, pseudotumor, metallosis and elevated cocr levels. During the revision surgery durom cup and head were revised. Kinectiv neck could not be disassociated from the femoral component hence it remains implanted along with g7 cup, screws, liner and head.
 
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Brand NameDUROM US ACET CMPNT 58/52 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 Key11541499
MDR Text Key241425930
Report Number0009613350-2021-00134
Device Sequence Number1
Product Code KWA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K053536
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
Remedial Action Notification
Type of Report Initial
Report Date 03/22/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/22/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date11/15/2012
Device Model NumberN/A
Device Catalogue Number01.00214.158
Device Lot Number2418288
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 Received03/02/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/03/2007
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction Number9613350-07/15/2008-001C

Patient Treatment Data
Date Received: 03/22/2021 Patient Sequence Number: 1
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