• 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 SECTOR W/GRIPTION 58MM 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 SECTOR W/GRIPTION 58MM PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS Back to Search Results
Model Number 1217-32-058
Device Problems Device Dislodged or Dislocated (2923); Noise, Audible (3273)
Patient Problem Insufficient Information (4580)
Event Date 11/22/2021
Event Type  Injury  
Event Description
It was reported that the patients right hip was revised due to the liner disassociating from the cup. The patient presented in clinic with an audible squeaking sound from his hip. After looking at the x-ray, it was apparent the head was articulating with the inside of the shell. The liner was removed and the head was removed. A head liner exchange was performed and all the other implants were retained. Doi: (b)(6) 2020 , dor: (b)(6) 2021 , (left hip).
 
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.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NamePINN SECTOR W/GRIPTION 58MM
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 dr.
warsaw, IN 46581-0988
6107428552
MDR Report Key12933711
MDR Text Key281746134
Report Number1818910-2021-27206
Device Sequence Number1
Product Code KWA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K093646
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 12/06/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/06/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number1217-32-058
Device Catalogue Number121732058
Device Lot Number9314217
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/21/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/22/2019
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: 12/06/2021 Patient Sequence Number: 1
Treatment
ALTRX NEUT 40IDX58OD; DLT TS CER HD 12/14 40MM +1.5; PINN CAN BONE SCREW 6.5MMX30MM; PINN SECTOR W/GRIPTION 58MM; SUMMIT POR TAPER SZ5 HI OFF
-
-