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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH REVITAN, PROXIMAL PART, CONICAL, UNCEMENTED, 85, TAPER 12/14 HIP PROSTHESIS

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ZIMMER SWITZERLAND MANUFACTURING GMBH REVITAN, PROXIMAL PART, CONICAL, UNCEMENTED, 85, TAPER 12/14 HIP PROSTHESIS Back to Search Results
Model Number N/A
Device Problems Loosening of Implant Not Related to Bone-Ingrowth (4002); Migration (4003)
Patient Problem Failure of Implant (1924)
Event Date 02/21/2022
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. Product has been received by zimmer biomet and the investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted. Concomitant medical devices: biolox delta, ceramic femoral head, m, 㸠32/0, taper 12/14; item: 00-8775-032-02; lot: 2552350 durasul alpha insert, jj/32; item: 01. 00013. 410; lot: 2541388. Multiple mdr reports were filed for this event, please see associated reports: 0009613350-2022-00167.
 
Event Description
It was reported that there was a revision due to wear of the connecting bolt and loosening from the distal part of the stem. The rx showed that the proximal part was no longer aligned straight.
 
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Brand NameREVITAN, PROXIMAL PART, CONICAL, UNCEMENTED, 85, TAPER 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 Key13858386
MDR Text Key287670135
Report Number0009613350-2022-00168
Device Sequence Number1
Product Code KWA
Combination Product (y/n)N
Reporter Country CodeSZ
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 04/12/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/23/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date07/31/2012
Device Model NumberN/A
Device Catalogue Number01.00401.085
Device Lot Number2399510
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/16/2022
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received03/15/2022
Was Device Evaluated by Manufacturer? No
Date Device Manufactured08/03/2007
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberN/A

Patient Treatment Data
Date Received: 03/23/2022 Patient Sequence Number: 1
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