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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 RECLAIM PRX BDY CONE 20X105; RECLAIM IMPLANT : HIP FEMORAL STEM
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DEPUY IRELAND - 9616671 RECLAIM PRX BDY CONE 20X105; RECLAIM IMPLANT : HIP FEMORAL STEM Back to Search Results
Catalog Number 197520105
Medical Device Problem Codes Loss of Osseointegration (2408); Osseointegration Problem (3003)
Health Effect - Clinical Codes Inadequate Osseointegration (2646); No Code Available (3191)
Date of Event 11/06/2019
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
Patient revised due to loosening of the cup at bone to implant interface.A new reclaim body and head were implanted.Doi: (b)(6) 2018; 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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch, a follow-up medwatch will be filed as appropriate.
 
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Brand Name
RECLAIM PRX BDY CONE 20X105
Common Device Name
RECLAIM IMPLANT : HIP FEMORAL STEM
Manufacturer (Section D)
DEPUY IRELAND - 9616671
loughbeg ringaskiddy co.
cork
EI 
MDR Report Key9403953
Report Number1818910-2019-119668
Device Sequence Number2166980
Product Code KWA
UDI-Device Identifier10603295076902
UDI-Public10603295076902
Combination Product (Y/N)N
Initial Reporter StateNY
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
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) 11/06/2019
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 Number197520105
Device Lot Number266368
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 11/06/2019
Supplement Date Received by Manufacturer12/12/2019
Initial Report FDA Received Date12/03/2019
Supplement Report FDA Received Date12/16/2019
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 36IDX52OD; ARTICULEZE M HEAD 36MM +12
Outcome Attributed to Adverse Event Required Intervention;
Patient Age75 YR
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