• 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 UNK HIP ACETABULAR LINER METAL PINNACLE METAL ACETABULAR LINER

  • 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 UNK HIP ACETABULAR LINER METAL PINNACLE METAL ACETABULAR LINER Back to Search Results
Catalog Number UNK HIP ACETABULAR LINER METAL
Device Problem Naturally Worn (2988)
Patient Problems Adhesion(s) (1695); Fatigue (1849); Foreign Body Reaction (1868); Hemorrhage/Bleeding (1888); Hypersensitivity/Allergic reaction (1907); Necrosis (1971); Pain (1994); Loss of Range of Motion (2032); Vertigo (2134); Distress (2329); Discomfort (2330); Deformity/ Disfigurement (2360); Numbness (2415); Paresthesia (4421); Unspecified Tissue Injury (4559); Physical Asymmetry (4573); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 06/25/2020
Event Type  Injury  
Event Description
Pinnacle litigation record received. Patient alleges pain, elevated metal ion, fatigue, tumor that caused by metallosis due to the initial implant of the metal-on-metal pinnacle device, hemarthrosis, numbness and discomfort, fluid accumulation, bleeding into the hip joint, and swelling. Patient developed a football-sized pseudotumor and related necrosis, caused by metallosis due to the initial implant of the metal-on-metal pinnacle device causing him emotional distress. Plaintiff sustained and continues to suffer damages, including, but not limited to suffering, severe and possibly permanent injuries, disability, disfigurement, economic damages (including medical and hospital expenses) monitoring, rehabilitative and pharmaceutical costs, and lost wages and loss of future earnings capacity, inability to walk without a cane, bone loss, parasthesia in right leg, mark distention in right hip, debris, kidney cancer, thyroid issues, bell's palsy, and vertigo. Doi: (b)(6) 2005 ; dor: (b)(6) 2020 ; (right hip).
 
Manufacturer Narrative
Product complaint # (b)(4). Initial reporter occupation: lawyer. (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 NameUNK HIP ACETABULAR LINER METAL PINNACLE
Type of DeviceMETAL ACETABULAR LINER
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 Key13306500
MDR Text Key284111604
Report Number1818910-2022-01215
Device Sequence Number1
Product Code KWA
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/20/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/20/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberUNK HIP ACETABULAR LINER METAL
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received01/20/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 01/20/2022 Patient Sequence Number: 1
Treatment
UNK HIP ACETABULAR CUP PINNACLE; UNK HIP ACETABULAR LINER METAL PINNACLE; UNK HIP FEMORAL HEAD METAL; UNKNOWN HIP FEMORAL STEM
-
-