• 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 SECTOR II CUP 48MM 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 SECTOR II CUP 48MM PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS Back to Search Results
Model Number 1217-22-048
Device Problems Malposition of Device (2616); Device Dislodged or Dislocated (2923)
Patient Problems Foreign Body Reaction (1868); Pain (1994); Ambulation Difficulties (2544); No Code Available (3191)
Event Date 05/10/2019
Event Type  Injury  
Manufacturer Narrative

(b)(4). Initial reporter occupation: lawyer. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

 
Event Description

Pinnacle claim reported that the patient was revised for subluxation and rupture of polyethylene. Doi: (b)(6) 2017; dor: (b)(6) 2019; left hip.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NamePINNACLE SECTOR II CUP 48MM
Type of DevicePINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
Manufacturer (Section G)
DEPUY ORTHOPAEDICS, INC. 1818910
700 orthopaedic dr.
warsaw IN 46581 0988
Manufacturer Contact
kara ditty-bovard
700 orthopaedic drive
warsaw, IN 46581-0988
6107428552
MDR Report Key10139243
MDR Text Key194675641
Report Number1818910-2020-13623
Device Sequence Number1
Product Code LPH
Combination Product (Y/N)N
PMA/PMN NumberK033273
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type CONSUMER,FOREIGN,OTHER
Type of Report Initial,Followup,Followup,Followup
Report Date 06/02/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/10/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number1217-22-048
Device Catalogue Number121722048
Device LOT Number8389232
Was Device Available For Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/17/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured09/23/2016
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 06/10/2020 Patient Sequence Number: 1
Treatment
APEX HOLE ELIM POSITIVE STOP; CORAIL2 STD SIZE 11; DELTA CER HEAD 12/14 32MM +5; PINN MAR +4 10D 32IDX48OD; PINNACLE SECTOR II CUP 48MM
-
-