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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 RECLAIM PRX BDY CONE 24X85; RECLAIM IMPLANT : HIP FEMORAL STEM
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DEPUY IRELAND - 9616671 RECLAIM PRX BDY CONE 24X85; RECLAIM IMPLANT : HIP FEMORAL STEM Back to Search Results
Model Number 1975-24-085
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes Unspecified Infection (1930); No Code Available (3191)
Date of Event 08/25/2020
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 as revision due to the presence of infection.Doi: (b)(6) 2020, dor: (b)(6) 2020, affected side: 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.
 
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Brand Name
RECLAIM PRX BDY CONE 24X85
Common Device Name
RECLAIM IMPLANT : HIP FEMORAL STEM
Manufacturer (Section D)
DEPUY IRELAND - 9616671
loughbeg ringaskiddy co.
cork
EI 
MDR Report Key10504443
Report Number1818910-2020-19552
Device Sequence Number3336508
Product Code KWA
UDI-Device Identifier10603295076926
UDI-Public10603295076926
Combination Product (Y/N)N
Initial Reporter StateNC
Initial Reporter CountryUS
PMA/510(K) Number
K102080
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2020
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) 08/25/2020
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? No
Operator of Device Health Professional
Device Model Number1975-24-085
Device Catalogue Number197524085
Device Lot NumberJ50A94
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 08/25/2020
Supplement Date Received by Manufacturer10/09/2020
Initial Report FDA Received Date09/08/2020
Supplement Report FDA Received Date10/12/2020
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
ALTRX NEUT 36IDX54OD; DELTA CER HEAD 12/14 36MM +5; PINN CAN BONE SCREW 6.5MMX25MM; PINN CAN BONE SCREW 6.5MMX25MM; ALTRX NEUT 36IDX54OD; DELTA CER HEAD 12/14 36MM +5; PINN CAN BONE SCREW 6.5MMX25MM; PINN CAN BONE SCREW 6.5MMX25MM
Outcome Attributed to Adverse Event Required Intervention;
Patient Age47 YR
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