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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SUMMIT POR TAPER SZ7 STD OFF; SUMMIT HIP STEM : HIP FEMORAL STEM
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DEPUY ORTHOPAEDICS INC US SUMMIT POR TAPER SZ7 STD OFF; SUMMIT HIP STEM : HIP FEMORAL STEM Back to Search Results
Model Number 1570-01-135
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event 06/01/2021
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).Clinical symptoms code: appropriate term/code not available (b)(4) used to capture infections.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 was infected.Doi: (b)(6) 2021: dor: (b)(6) 2021: left hip.
 
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Brand Name
SUMMIT POR TAPER SZ7 STD OFF
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 Key12084050
Report Number1818910-2021-13771
Device Sequence Number14289950
Product Code LPH
UDI-Device Identifier10603295059387
UDI-Public10603295059387
Combination Product (Y/N)N
Initial Reporter StateMI
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2021
Device Explanted Year2021
Serviced by Third Party (Y/N)Unknown
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date (Section B) 06/01/2021
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
Operator of Device Health Professional
Device Model Number1570-01-135
Device Catalogue Number157001135
Device Lot Number9676281
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 06/01/2021
Supplement Date Received by Manufacturer07/16/2021
Initial Report FDA Received Date06/29/2021
Supplement Report FDA Received Date07/19/2021
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 NEUT 36IDX52OD; DELTA CER HEAD 12/14 36MM +5; PINNACLE SECTOR II CUP 52MM; SUMMIT POR TAPER SZ7 STD OFF; ALTRX NEUT 36IDX52OD; DELTA CER HEAD 12/14 36MM +5; PINNACLE SECTOR II CUP 52MM; SUMMIT POR TAPER SZ7 STD OFF
Outcome Attributed to Adverse Event Required Intervention;
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