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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY IRELAND - 3015516266 PINNACLE DM LINER 52_45; TOTAL HIP JOINT REPLACEMENT PROSTHESIS
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DEPUY IRELAND - 3015516266 PINNACLE DM LINER 52_45; TOTAL HIP JOINT REPLACEMENT PROSTHESIS Back to Search Results
Model Number 1218-52-045
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code Unspecified Infection (1930)
Date of Event 09/17/2021
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 due to infection.Doi: unknown.Dor: (b)(6) 2021.Affected side: unknown 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 material, manufacturing, inspection or sterile processing 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
PINNACLE DM LINER 52_45
Common Device Name
TOTAL HIP JOINT REPLACEMENT PROSTHESIS
Manufacturer (Section D)
DEPUY IRELAND - 3015516266
loughbeg ringaskiddy co.
cork
EI 
MDR Report Key12563111
Report Number1818910-2021-21743
Device Sequence Number1205783
Product Code LPH
UDI-Device Identifier10603295520276
UDI-Public10603295520276
Combination Product (Y/N)N
Initial Reporter StateSC
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
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) 09/17/2021
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 Number1218-52-045
Device Catalogue Number121852045
Device Lot Number9691950
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 09/17/2021
Supplement Date Received by Manufacturer10/28/2021
Initial Report FDA Received Date10/01/2021
Supplement Report FDA Received Date10/29/2021
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
APEX HOLE ELIM POSITIVE STOP; ARTICUL/EZE BALL 22.225+4 NK; BI MENTUM PFRK PE LINER 22 45; CORAIL2 LAT COXA VARA SIZE 12; PINN 100 W/GRIPTION 52MM; PINNACLE DM LINER 52_45; APEX HOLE ELIM POSITIVE STOP; ARTICUL/EZE BALL 22.225+4 NK; BI MENTUM PFRK PE LINER 22 45; CORAIL2 LAT COXA VARA SIZE 12; PINN 100 W/GRIPTION 52MM; PINNACLE DM LINER 52_45
Outcome Attributed to Adverse Event Required Intervention;
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