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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SUMMIT CEMENTED STEM SZ7 STD; SUMMIT HIP STEM : HIP FEMORAL STEM
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DEPUY ORTHOPAEDICS INC US SUMMIT CEMENTED STEM SZ7 STD; SUMMIT HIP STEM : HIP FEMORAL STEM Back to Search Results
Catalog Number 157003135
Medical Device Problem Code Loss of or Failure to Bond (1068)
Health Effect - Clinical Code No Code Available (3191)
Date of Event 06/18/2019
Type of Reportable Event Serious Injury
Additional 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 or Problem Description
It was reported that the patient underwent a summit cemented construct several years ago.Unfortunately, it was found that the stem was indeed loose at the cement to implant interface.Depuy cement was used.It was also indicated that it is unsure exactly what caused this loosening.The patient was revised to a reclaim construct.Doi: (b)(6) 2014.Dor: june 18, 2019.Right hip.
 
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provision of 21 cfr, part 803.The report may be based on the information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Product complaint # (b)(4).No device associated with this report was received for examination.A worldwide complaint database search found no other related reported incidents against the provided product code/lot number combination since release for distribution.Based on previous investigations, this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications.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.Device history lot : null.Device history batch : null.Device history review : null.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
SUMMIT CEMENTED STEM SZ7 STD
Common Device Name
SUMMIT HIP STEM : HIP FEMORAL STEM
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46582 0988
MDR Report Key8771075
Report Number1818910-2019-97795
Device Sequence Number11184913
Product Code JDI
UDI-Device Identifier10603295059578
UDI-Public10603295059578
Combination Product (Y/N)N
Initial Reporter StateCO
Initial Reporter CountryUS
PMA/510(K) Number
K013352
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2014
Device Explanted Year2019
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date (Section B) 06/18/2019
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? Yes
Operator of Device Health Professional
Device Catalogue Number157003135
Device Lot NumberD14060764
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 06/18/2019
Supplement Date Received by Manufacturer07/15/2019
Initial Report FDA Received Date07/09/2019
Supplement Report FDA Received Date07/16/2019
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
ALTRX +4 NEUT 36IDX54OD; ARTICULEZE M HEAD 36MM +1.5; CEMENTRALIZER 14.0; PINN CAN BONE SCREW 6.5MMX30MM; PINN CAN BONE SCREW 6.5MMX35MM; PINNACLE SECTOR II CUP 54MM; ALTRX +4 NEUT 36IDX54OD; ARTICULEZE M HEAD 36MM +1.5; CEMENTRALIZER 14.0; PINN CAN BONE SCREW 6.5MMX30MM; PINN CAN BONE SCREW 6.5MMX35MM; PINNACLE SECTOR II CUP 54MM
Outcome Attributed to Adverse Event Required Intervention;
Patient Age78 YR
Patient Weight84
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