• 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 CAN BONE SCREW 6.5MMX20MM BONE SCREWS AND PINS : SCREWS

  • 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 CAN BONE SCREW 6.5MMX20MM BONE SCREWS AND PINS : SCREWS Back to Search Results
Model Number 1217-20-500
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Wound Dehiscence (1154); Calcium Deposits/Calcification (1758); Hemorrhage/Bleeding (1888); Unspecified Infection (1930); Inflammation (1932); Pain (1994); Weakness (2145); Ambulation Difficulties (2544); Limited Mobility Of The Implanted Joint (2671); Fibrosis (3167); No Code Available (3191)
Event Date 01/15/2013
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
Patient was revised to address infection. Loosening of the cup and stem due to the infection was also reported. Update ad 2 jul 2020: (b)(4) has been re-opened under (b)(4) due to medical records received. After review of medical record, the patient was revised to address infection, osteomyelitis, pain, fracture of the greater trochanter and heterotopic bone formation along the medical calcar. Persistent purulent drainage from her lateral hip wound. Operative note reported abundant amount of fibrous tissue surrounding the hip joint. Frozen section revealed acute inflammation consistent with infection. Stem revealed it to be grossly loose. Notable drainage from her right hip wound. Removal of tha with placement of antibiotic impregnated spacer, biopsy, i and d were performed. Doi: (b)(6) 2012: dor: (b)(6) 2013: right hip 2nd revision (head and stem). Doi: (b)(6) 2012: dor: (b)(6) 2013: right hip (cup, linear and screws). Added revision hospital, medical history, dob, height, ethnicity, race, law firm name, patient harm, litigation box was ticked, pe code for the stem and concomitant products. Added product details for screws. Corrected patient identifier. This complaint was reviewed and updated on jul 13, 2020.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NamePINN CAN BONE SCREW 6.5MMX20MM
Type of DeviceBONE SCREWS AND PINS : SCREWS
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
Manufacturer (Section G)
JJMSZ PLANT FOR STK. & N-STK.
no. 299, changyang street
suzhou industrial park
suzhou, jiangsu 21512 6
CH 215126
Manufacturer Contact
kara ditty-bovard
700 orthopaedic drive
warsaw, IN 46581-0988
6107428552
MDR Report Key10296501
MDR Text Key200794806
Report Number1818910-2020-16250
Device Sequence Number1
Product Code KWA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K073504
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,other
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup
Report Date 01/15/2013
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/20/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number1217-20-500
Device Catalogue Number121720500
Device Lot NumberD12042599
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/25/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/30/2012
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: 07/20/2020 Patient Sequence Number: 1
-
-