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U.S. Department of Health and Human Services

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

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DEPUY ORTHOPAEDICS INC US UNK HIP FEMORAL STEM SUMMIT Back to Search Results
Catalog Number UNK HIP FEMORAL STEM SUMMIT
Device Problem Loss of Osseointegration (2408)
Patient Problems Pain (1994); Inadequate Osseointegration (2646); No Code Available (3191)
Event Date 10/21/2020
Event Type  Injury  
Manufacturer Narrative
Product complaint #: (b)(4). Investigation summary: no device associated with this report was received for examination. A worldwide lot specific complaint database search, or manufacturing record evaluation, was not possible as the required lot number was not provided. The information received will be retained for trend analysis, post market surveillance, or other events within the quality system. (b)(4).
 
Event Description
It was reported that the patient had a hip fracture on (b)(6) 2020, and a summit basic unipolar hemi arthroplasty. The patient returned to surgery today due to a painful hip and loosening of the stem at bone to implant interface and revision to a cemented summit total hip. Doi: (b)(6) 2020, dor: (b)(6) 2020, left hip.
 
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Brand NameUNK HIP FEMORAL STEM SUMMIT
Type of DeviceFEMORAL 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 Key10808852
MDR Text Key215279553
Report Number1818910-2020-24166
Device Sequence Number1
Product Code KWY
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 10/21/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/09/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberUNK HIP FEMORAL STEM SUMMIT
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 Received10/21/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 11/09/2020 Patient Sequence Number: 1
Treatment
(0 NECK); (45 MOD CATHCART)
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