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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH REVITAN, DISTAL PART, CURVED, UNCEMENTED, 18/140 HIP PROSTHESIS

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ZIMMER SWITZERLAND MANUFACTURING GMBH REVITAN, DISTAL PART, CURVED, UNCEMENTED, 18/140 HIP PROSTHESIS Back to Search Results
Model Number N/A
Device Problems Unstable (1667); Biocompatibility (2886); Patient Device Interaction Problem (4001)
Patient Problems Failure of Implant (1924); Joint Laxity (4526)
Event Date 07/13/2021
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. Medical products: revitan, proximal part, cylindrical, uncemented, 105, taper 12/14; catalog#: 01. 00402. 105; lot#: 3054979. Revitan, disassembly sleeve; catalog#: 01. 00409. 816; lot#: unknown. Revitan, disassembly instrument; catalog#: 01. 00409. 801; lot#: 05. 161079. Revitan, rod for disassembly instrument, threaded; catalog#: 01. 00409. 803; lot#: 06. 224533. Therapy date: (b)(6) 2021. The manufacturer received x-rays for review. Other documents were received and will be reviewed as part of ongoing investigation. The manufacturer did not receive the device for investigation. As no lot number was provided, the device history records could not be reviewed. 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 biomets reference number of this file is (b)(4).
 
Event Description
Patient was implanted on the left side and underwent a revision surgery due to instability. The surgery was delayed by 60 min, since the instrument could not be loosened.
 
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Brand NameREVITAN, DISTAL PART, CURVED, UNCEMENTED, 18/140
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 Key12347387
MDR Text Key267431318
Report Number0009613350-2021-00414
Device Sequence Number1
Product Code KWA
Combination Product (y/n)N
Reporter Country CodeGM
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 11/19/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/20/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue Number01.00406.118
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/25/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received11/15/2021
Was Device Evaluated by Manufacturer? Yes
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: 08/20/2021 Patient Sequence Number: 1
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