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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SUMMIT BASIC CEMENTED SZ 3; SUMMIT HIP STEM : HIP FEMORAL STEM
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DEPUY ORTHOPAEDICS INC US SUMMIT BASIC CEMENTED SZ 3; SUMMIT HIP STEM : HIP FEMORAL STEM Back to Search Results
Model Number 1570-06-090
Medical Device Problem Code Loss of or Failure to Bond (1068)
Health Effect - Clinical Codes Fall (1848); No Code Available (3191)
Date of Event 04/25/2020
Type of Reportable Event Serious Injury
Additional 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 or Problem Description
It was reported that received patient fall.Implant dislocation due to disassociation from cement.Implant was easily removed and came out free of any cement.Doi: unknown.Dor: (b)(6) 2020; left side.
 
Additional Manufacturer Narrative
Product complaint # : (b)(4).Investigation summary : no device associated with this report was received for examination.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed, and the investigation will be re-opened as necessary.
 
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Brand Name
SUMMIT BASIC CEMENTED SZ 3
Common Device Name
SUMMIT HIP STEM : HIP FEMORAL STEM
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
MDR Report Key10039146
Report Number1818910-2020-11890
Device Sequence Number14221108
Product Code JDI
UDI-Device Identifier10603295059769
UDI-Public10603295059769
Combination Product (Y/N)N
Initial Reporter StateUT
Initial Reporter CountryUS
PMA/510(K) Number
K023453
Number of Events Summarized1
Summary Report (Y/N)N
Device Explanted Year2020
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date (Section B) 04/25/2020
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? Yes
Operator of Device Health Professional
Device Model Number1570-06-090
Device Catalogue Number157006090
Device Lot NumberD19091309
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 04/25/2020
Supplement Date Received by Manufacturer06/19/2020
Initial Report FDA Received Date05/08/2020
Supplement Report FDA Received Date06/22/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Concomitant Medical Products
and Therapy/Usage Dates
CEMENTRALIZER 8.5MM; COMPETITOR CEMENT; MODULAR CATHCART BALL 44MM OD; TAPERED SPACER ARTICUL/EZE +0; CEMENTRALIZER 8.5MM; COMPETITOR CEMENT; MODULAR CATHCART BALL 44MM OD; TAPERED SPACER ARTICUL/EZE +0
Outcome Attributed to Adverse Event Required Intervention;
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