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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SUMMIT POR TAPER SZ3 HI OFF; SUMMIT HIP STEM : HIP FEMORAL STEM
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DEPUY ORTHOPAEDICS INC US SUMMIT POR TAPER SZ3 HI OFF; SUMMIT HIP STEM : HIP FEMORAL STEM Back to Search Results
Model Number 1570-11-090
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes Extraskeletal ossification (1428); Calcium Deposits/Calcification (1758); Foreign Body Reaction (1868); Inflammation (1932); Pain (1994); Tissue Damage (2104); Test Result (2695); No Code Available (3191)
Date of Event 12/02/2019
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
(b)(4).Initial reporter occupation: lawyer.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
After review of medical records patient was revised to addressed left failed total hip arthroplasty pain, metallosis, small abductor tear and inflammation.Operatives notes indicated elevated metal ion level and heterotopic ossification.Doi: (b)(6) 2007.Dor: (b)(6) 2019; left hip.
 
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.H10 additional narrative: added: h6 patient code.H6 patient code: no code available (3191) used to capture the blood heavy metal increased.
 
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Brand Name
SUMMIT POR TAPER SZ3 HI 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 Key10076525
Report Number1818910-2020-12378
Device Sequence Number14165253
Product Code LPH
UDI-Device Identifier10603295060048
UDI-Public10603295060048
Combination Product (Y/N)N
Initial Reporter StateIL
Initial Reporter CountryUS
PMA/510(K) Number
K001991
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2007
Reporter Type Manufacturer
Report Source consumer,other
Initial Reporter Occupation Other
Type of Report Initial,Followup
Report Date (Section B) 05/05/2020
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? No
Operator of Device Health Professional
Device Model Number1570-11-090
Device Catalogue Number157011090
Device Lot NumberA6AEG1000
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 05/05/2020
Supplement Date Received by Manufacturer07/02/2020
Initial Report FDA Received Date05/20/2020
Supplement Report FDA Received Date07/02/2020
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
ADAPTER SLEEVES 12/14 +2; ASR ACETABULAR CUPS 50; ASR UNI FEMORAL IMPL SIZE 45; SUMMIT POR TAPER SZ3 HI OFF; ADAPTER SLEEVES 12/14 +2; ASR ACETABULAR CUPS 50; ASR UNI FEMORAL IMPL SIZE 45; SUMMIT POR TAPER SZ3 HI OFF
Outcome Attributed to Adverse Event Required Intervention;
Patient Age63 YR
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