Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINNACLE 100 ACET CUP 54MM; PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

DEPUY ORTHOPAEDICS INC US PINNACLE 100 ACET CUP 54MM; PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS Back to Search Results
Model Number 1217-01-054
Medical Device Problem Code Difficult to Remove (1528)
Health Effect - Clinical Code Pain (1994)
Date of Event 12/02/2020
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
This is a revision of the corail and pinnacle hip.This was revised due to the corail stem's subsidence, and the ceramic lined was chipping off.Patient experiencing pain.
 
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.Photographs of the explanted device were provided the cup and liner are yet assembled in the provided photographic image.It does not aid in determining a root cause.It is not possible to determine a root cause using photographic images.The information received will be retained for potential series investigations if triggered by trend analysis 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: a device history record (mre) review, was not possible because the required lot code was not provided.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
PINNACLE 100 ACET CUP 54MM
Common Device Name
PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
MDR Report Key11087721
Report Number1818910-2020-27748
Device Sequence Number3561059
Product Code LPH
UDI-Device Identifier10603295008569
UDI-Public10603295008569
Combination Product (Y/N)N
Initial Reporter CountryCA
PMA/510(K) Number
P070026
Number of Events Summarized1
Summary Report (Y/N)N
Device Explanted Year2020
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) 12/02/2020
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 Number1217-01-054
Device Catalogue Number121701054
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 12/14/2020
Supplement Date Received by Manufacturer02/24/2021
Initial Report FDA Received Date12/29/2020
Supplement Report FDA Received Date02/24/2021
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
CERAMAX CERAMIC INSERT 36 X 54; CORAIL2 NON COL HO SIZE 11; DELTA CER HEAD 12/14 36MM +5; CERAMAX CERAMIC INSERT 36 X 54; CORAIL2 NON COL HO SIZE 11; DELTA CER HEAD 12/14 36MM +5
Outcome Attributed to Adverse Event Required Intervention;
-
-