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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, 20/140 N/A

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ZIMMER SWITZERLAND MANUFACTURING GMBH REVITAN, DISTAL PART, CURVED, UNCEMENTED, 20/140 N/A Back to Search Results
Model Number N/A
Device Problem Fracture (1260)
Patient Problems Failure of Implant (1924); Pain (1994)
Event Date 10/01/2019
Event Type  Injury  
Manufacturer Narrative
The manufacturer did not receive x-rays, or other source documents for review. The manufacturer did not receive the device yet, however it is indicated by complainant that it will be returned for investigation. As no lot number was provided, the device history records could not be reviewed. An e-mail requesting the following additional information was sent to the appropriate representatives: please clarify the correct notification date: is it the 14. 10. 2019 or 15. 10. 2019. Ref: (b)(4) please provide us the lot number. Exact implant date. Implantation report. Revision report. All available x-rays during time in- vivo with printed date. All available intraoperative pictures. Patient dob, weight, height, bmi and all relevant history. Did a delay in the procedure occur that was related to the event? if yes, time surgery was extended? were there any contributing conditions related to the event? (ex: trauma, illness, previous surgery, related non-compliance, patient anatomy) was the surgical technique for the product utilized? concomitant medical product: unknown revitan distal stem hip, item#: unknown, lot#: unknown. 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. (b)(4).
 
Event Description
It was reported that product was implanted in 2006 and revised due to pain and implant fracture.
 
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Brand NameREVITAN, DISTAL PART, CURVED, UNCEMENTED, 20/140
Type of DeviceN/A
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 Key9250355
MDR Text Key164263968
Report Number0009613350-2019-00637
Device Sequence Number1
Product Code MEH
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 12/14/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/29/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/15/2008
Device Model NumberN/A
Device Catalogue Number01.00406.120
Device Lot Number2192419
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/13/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received10/15/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/11/2003
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Invalid Data
Removal/Correction NumberN/A

Patient Treatment Data
Date Received: 10/29/2019 Patient Sequence Number: 1
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