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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH METASUL LDH, HEAD, 48, CODE N, TAPER 18/20 HIP PROSTHESIS

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ZIMMER SWITZERLAND MANUFACTURING GMBH METASUL LDH, HEAD, 48, CODE N, TAPER 18/20 HIP PROSTHESIS Back to Search Results
Model Number N/A
Device Problems Biocompatibility (2886); Appropriate Term/Code Not Available (3191)
Patient Problems Foreign Body Reaction (1868); Local Reaction (2035); Osteolysis (2377)
Event Date 03/10/2021
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: zimmer mmc, cup, uncemented, 56 mm/48 mm, code n; catalog#: 01. 00634. 056; lot#: 2528553; metasul ldha, head adapter, m, 0, taper 12/14-18/20; catalog#: 01. 00185. 146; lot#: 2585758; fitmore, hip stem, uncemented, b/7, taper 12/14; catalog#: 01. 00551. 207; lot#: 2538809. Therapy date: (b)(6) 2021. The manufacturer received other source 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 was implanted on an unknown side and underwent a revision surgery due to massive acetabular osteolysis, metallosis (trunionosis) and elevated metal ions in blood. The stem was retained during the revision surgery and other components have been explanted.
 
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Brand NameMETASUL LDH, HEAD, 48, CODE N, TAPER 18/20
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 Key11617890
MDR Text Key243905925
Report Number0009613350-2021-00161
Device Sequence Number1
Product Code KWA
Combination Product (y/n)N
Reporter Country CodeSP
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,Followup
Report Date 11/04/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/06/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/28/2015
Device Model NumberN/A
Device Catalogue Number01.00181.480
Device Lot Number2543942
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/02/2011
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received10/20/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/08/2010
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: 04/06/2021 Patient Sequence Number: 1
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