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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNKNOWN HIP INSTRUMENTS

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DEPUY ORTHOPAEDICS INC US UNKNOWN HIP INSTRUMENTS Back to Search Results
Catalog Number UNK HIP INSTRUMENTS
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Not Applicable (3189)
Event Date 06/17/2019
Event Type  Injury  
Manufacturer Narrative
Product complaint # (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
It was reported that the patient on hana table for a left direct anterior approach (daa) total hip replacement (thr).The surgeon perforated left proximal femur at the level of the lesser trochanter with a trilock broach.The surgeon switched to summit to bypass the fracture.Threaded inserted used to impact stem.Tip of inserter sheared off in top of stem.Stem remained in place.Head ball applied to stem trunion and hip reduced.Threaded fragment cold welded into stem.10 minutes surgical delay.
 
Manufacturer Narrative
Product complaint # (b)(4).Investigation summary
=
> the instrument associated with this report was not returned.The root cause could not be determined.Depuy considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation will 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.
 
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Brand Name
UNKNOWN HIP INSTRUMENTS
Type of Device
HIP INSTRUMENTS
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46582 0988
Manufacturer (Section G)
DEPUY ORTHOPAEDICS, INC. 1818910
700 orthopaedic dr.
warsaw IN 46582 0988
Manufacturer Contact
kara ditty-bovard
1210 ward avenue
west chester, PA 19380-0988
6107428552
MDR Report Key8769017
MDR Text Key150315301
Report Number1818910-2019-97759
Device Sequence Number1
Product Code KWA
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,Followup
Report Date 06/17/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue NumberUNK HIP INSTRUMENTS
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 06/17/2019
Initial Date FDA Received07/08/2019
Supplement Dates Manufacturer Received08/12/2019
Supplement Dates FDA Received08/12/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age69 YR
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