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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 RECLAIM DISTAL TAPERED 19X140; RECLAIM IMPLANT : HIP FEMORAL STEM
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DEPUY IRELAND - 9616671 RECLAIM DISTAL TAPERED 19X140; RECLAIM IMPLANT : HIP FEMORAL STEM Back to Search Results
Model Number 1976-19-140
Medical Device Problem Code Osseointegration Problem (3003)
Health Effect - Clinical Code Inadequate Osseointegration (2646)
Date of Event 11/11/2020
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
The patient was revised to address aseptic loosening of reclaim femoral component at the bone to implant interface.No surgical delay.Doi: (b)(6) 2019 - dor: (b)(6) 2020 (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.Device history lot: the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.
 
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Brand Name
RECLAIM DISTAL TAPERED 19X140
Common Device Name
RECLAIM IMPLANT : HIP FEMORAL STEM
Manufacturer (Section D)
DEPUY IRELAND - 9616671
loughbeg ringaskiddy co.
cork
EI 
MDR Report Key10896485
Report Number1818910-2020-25388
Device Sequence Number16965424
Product Code KWA
UDI-Device Identifier10603295077091
UDI-Public10603295077091
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 Year2019
Device Explanted Year2020
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) 11/11/2020
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 Number1976-19-140
Device Catalogue Number197619140
Device Lot NumberHD4975
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 11/11/2020
Supplement Date Received by Manufacturer01/04/2021
Initial Report FDA Received Date11/24/2020
Supplement Report FDA Received Date01/05/2021
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
DELTA CER HEAD 12/14 36MM +1.5; RECLAIM PRX BDY CONE 24X85; DELTA CER HEAD 12/14 36MM +1.5; RECLAIM PRX BDY CONE 24X85
Outcome Attributed to Adverse Event Required Intervention;
Patient Age55 YR
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