• 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. 1818910 UNKNOWN HIP FEMORAL HEAD

  • 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. 1818910 UNKNOWN HIP FEMORAL HEAD Back to Search Results
Catalog Number UNK HIP FEMORAL HEAD
Device Problems Corroded (1131); Fracture (1260); Device Dislodged or Dislocated (2923); Naturally Worn (2988); Noise, Audible (3273)
Patient Problems Fatigue (1849); Unspecified Infection (1930); Inflammation (1932); Necrosis (1971); Pain (1994); Tissue Damage (2104); Discomfort (2330); Injury (2348); Joint Dislocation (2374); Limited Mobility Of The Implanted Joint (2671); Test Result (2695)
Event Type  Injury  
Manufacturer Narrative
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate. Device was used for treatment, not diagnosis. This report is for an unknown device/unknown lot. Part and lot number are unknown; udi number is unknown.
 
Event Description
Pinnacle mom litigation record received. Litigation alleges biologic corrosion and friction wear caused cocr metal ions and particles to be released into the plaintiff's body resulting to bodily injuries, pain, discomfort, crushing or popping noises, difficulty standing or walking, hip fractures or dislocations, fatigue, infection, necrosis, metallosis, and inflammation causing damage or death to surrounding bone and tissues. Doi: (b)(6) 2008; dor: not reported, (right hip).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameUNKNOWN HIP FEMORAL HEAD
Type of DeviceHIP FEMORAL HEAD
Manufacturer (Section D)
DEPUY ORTHOPAEDICS, INC. 1818910
700 orthopaedic drive
warsaw IN 46582 0988
Manufacturer (Section G)
DEPUY ORTHOPAEDICS, INC. 1818910
700 orthopaedic drive
warsaw IN 46582 0988
Manufacturer Contact
kara ditty-bovard
1210 ward avenue
west chester, PA 19380-0988
6103142063
MDR Report Key8436295
MDR Text Key139323578
Report Number1818910-2019-87846
Device Sequence Number1
Product Code KWY
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
UNK
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,other
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/28/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/20/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberUNK HIP FEMORAL HEAD
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 Received04/03/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 03/20/2019 Patient Sequence Number: 1
-
-