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 PINN MULTIHOLE W/GRIPTION 56MM; 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 PINN MULTIHOLE W/GRIPTION 56MM; PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS Back to Search Results
Model Number 1217-30-056
Medical Device Problem Code Loss of Osseointegration (2408)
Health Effect - Clinical Codes Inadequate Osseointegration (2646); No Code Available (3191)
Date of Event 08/03/2020
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
The patient was revised to address loosening of the cup at the bone to implant interface.No further information provided.Doi: (b)(6) 2020, dor: (b)(6) 2020, affected side: right 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.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
PINN MULTIHOLE W/GRIPTION 56MM
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 Key10408031
Report Number1818910-2020-18127
Device Sequence Number19613087
Product Code LPH
UDI-Device Identifier10603295010005
UDI-Public10603295010005
Combination Product (Y/N)N
Initial Reporter StateNC
Initial Reporter CountryUS
PMA/510(K) Number
K071784
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2020
Device Explanted Year2020
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date (Section B) 08/03/2020
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 Number1217-30-056
Device Catalogue Number121730056
Device Lot NumberJ68U34
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 08/03/2020
Supplement Date Received by Manufacturer09/15/2020
Initial Report FDA Received Date08/14/2020
Supplement Report FDA Received Date09/16/2020
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 10D 36IDX56OD; DELTA CER HEAD 11/13 36MM +0; PINN CAN BONE SCREW 6.5MMX20MM; ALTRX +4 10D 36IDX56OD; DELTA CER HEAD 11/13 36MM +0; PINN CAN BONE SCREW 6.5MMX20MM
Outcome Attributed to Adverse Event Required Intervention;
-
-