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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNKNOWN HIP FEMORAL STEM

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DEPUY ORTHOPAEDICS INC US UNKNOWN HIP FEMORAL STEM Back to Search Results
Catalog Number UNK HIP FEMORAL STEM
Device Problems Corroded (1131); Degraded (1153)
Patient Problem No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative
(b)(4). If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
Event Description
The primary surgery was performed on an unknown date. It was reported that a revision surgery was performed on an unknown date by replacing c-stem (p/n: unknown). The surgeon found that there was something like a corrosion from the middle to distal part of the explanted stem. This complaint is related to 11 complaints ((b)(4)), and 8 out of 12 (including this pc) complaints has been reported that there was corrosion of stem, but also, it¿s not determined which complaint has been involved. No further information is available.
 
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Brand NameUNKNOWN HIP FEMORAL STEM
Type of DeviceHIP FEMORAL STEM
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
Manufacturer (Section G)
DEPUY ORTHOPAEDICS, INC. 1818910
700 orthopaedic dr.
warsaw IN 46581 0988
Manufacturer Contact
kara ditty-bovard
700 orthopaedic drive
warsaw, IN 46581-0988
6107428552
MDR Report Key9873293
MDR Text Key186269348
Report Number1818910-2020-09069
Device Sequence Number1
Product Code KWY
Combination Product (y/n)N
Reporter Country CodeJA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 03/06/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/24/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberUNK HIP FEMORAL STEM
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/15/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 03/24/2020 Patient Sequence Number: 1
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