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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US MODIFIED HUDSON ADAPTER KNEE INSTRUMENT : ADAPTORS

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DEPUY ORTHOPAEDICS INC US MODIFIED HUDSON ADAPTER KNEE INSTRUMENT : ADAPTORS Back to Search Results
Catalog Number 217863136
Device Problems Connection Problem (2900); Device-Device Incompatibility (2919); Material Deformation (2976); Naturally Worn (2988)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/29/2019
Event Type  malfunction  
Manufacturer Narrative
Product complaint # b)(4). Investigation summary
==
> the device was reviewed and confirmed the device is worn. Root cause attributed to the device being worn from normal use and servicing. Depuy synthes considers the investigation closed at this time. Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
Manufacturer Narrative
Product complaint # (b)(4). Investigation summary: the device was reviewed and confirmed the device is worn. Root cause attributed to the device being worn from normal use and servicing. Depuy synthes considers the investigation closed at this time. Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
Event Description
Did a noiles / lps case yesterday at (b)(6). The following instruments from the loan kit need looking at 865226 stem trial extractor ¿ tip is bent, 217863134 sleeve clamp ¿ locking handle doesn't appear to be working correctly, 217863136 hudson adapter ¿ not locking onto the revision reamers.
 
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Brand NameMODIFIED HUDSON ADAPTER
Type of DeviceKNEE INSTRUMENT : ADAPTORS
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
1210 ward avenue
west chester, PA 19380-0988
6107428552
MDR Report Key9364836
MDR Text Key184382545
Report Number1818910-2019-117684
Device Sequence Number1
Product Code HWE
Combination Product (y/n)N
Reporter Country CodeUK
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,o
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 10/29/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/22/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number217863136
Device Lot NumberTBHEE
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/12/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/24/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/07/2014
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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