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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINN MAR LIP LNR 28IDX50OD; PINNACLE HIP SYSTEM : HIP POLY ACETABULAR LINERS
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DEPUY ORTHOPAEDICS INC US PINN MAR LIP LNR 28IDX50OD; PINNACLE HIP SYSTEM : HIP POLY ACETABULAR LINERS Back to Search Results
Model Number 1219-28-250
Medical Device Problem Code Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes Pain (1994); Joint Dislocation (2374)
Date of Event 02/11/2021
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
Chronic dislocation of thr.Liner replaced for constrained liner.Stem/cup remained insitu.Corail pinnacle thr (b)(6) 2017.
 
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
PINN MAR LIP LNR 28IDX50OD
Common Device Name
PINNACLE HIP SYSTEM : HIP POLY ACETABULAR LINERS
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
MDR Report Key11378610
Report Number1818910-2021-03855
Device Sequence Number3865859
Product Code LPH
UDI-Device Identifier10603295013617
UDI-Public10603295013617
Combination Product (Y/N)N
Initial Reporter CountryAS
PMA/510(K) Number
K001534
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2017
Device Explanted Year2021
Serviced by Third Party (Y/N)Unknown
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date (Section B) 02/12/2021
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? Yes
Operator of Device Health Professional
Device Model Number1219-28-250
Device Catalogue Number121928250
Device Lot NumberH41360
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 02/12/2021
Supplement Date Received by Manufacturer04/20/2021
Initial Report FDA Received Date02/25/2021
Supplement Report FDA Received Date04/20/2021
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; DELTA CER HEAD 12/14 28MM +1.5; PINN MAR LIP LNR 28IDX50OD; APEX HOLE ELIM POSITIVE STOP; DELTA CER HEAD 12/14 28MM +1.5; PINN MAR LIP LNR 28IDX50OD
Outcome Attributed to Adverse Event Required Intervention;
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