• 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 MTL INS NEUT36IDX50OD PINNACLE HIP SYSTEM : HIP METAL ACETABULAR LINERS

  • 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 MTL INS NEUT36IDX50OD PINNACLE HIP SYSTEM : HIP METAL ACETABULAR LINERS Back to Search Results
Catalog Number 121887350
Device Problem Naturally Worn (2988)
Patient Problems Foreign Body Reaction (1868); Hypersensitivity/Allergic reaction (1907); Necrosis (1971); Pain (1994); Loss of Range of Motion (2032); Distress (2329); Osteolysis (2377); Ambulation Difficulties (2544); Fibrosis (3167); Physical Asymmetry (4573); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 10/18/2019
Event Type  Injury  
Manufacturer Narrative
(b)(4). Initial reporter occupation: lawyer. Follow-up is being conducted to obtain legal contact information. If/when the contact information is received, a supplemental med watch report will be submitted. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
Event Description
Pinnacle unf and medical record received. After review of the medical records the patient was revised due to symptomatic metallosis, pseudotumor, alval, elevated metal ions, crp and sedimentation rate resulting to pain, bone necrosis of the proximal femur, large lytic lesion of the ischium, limp and leg length difference. Operative note reported pseudotumor fluid collection approx. 15 cc of red serosanguinous fluid. There is significant pseudo-capsular expansion and grade tinted stained tissue consistent with metal debris and damage. Cup looks vertical and anteverted related to spinal pelvic imbalance. Compromise of the abductors by the necrosis of the trochanter from the metallosis damage. Pathology report component had thick fibrosis and synovial lining eroded. Moderate grade for alval. Lab result for chromium and cobalt shows above 7 ppb. Doi: 2009: dor: (b)(6) 2019; left hip.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NamePINNACLE MTL INS NEUT36IDX50OD
Type of DevicePINNACLE HIP SYSTEM : HIP METAL ACETABULAR LINERS
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
Manufacturer (Section G)
DEPUY INT'L LTD. 8010379
st. anthony's rd
leeds LS11 8 DT
UK LS11 8 DT
Manufacturer Contact
kara ditty-bovard
700 orthopaedic dr.
warsaw, IN 46581-0988
6107428552
MDR Report Key11349533
MDR Text Key232597232
Report Number1818910-2021-03437
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 consumer,other
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup
Report Date 02/03/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/19/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number121887350
Device Lot Number2812609
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 Received04/16/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/08/2009
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberN/A

Patient Treatment Data
Date Received: 02/19/2021 Patient Sequence Number: 1
Treatment
ARTICULEZE M HEAD 36MM +1.5; DEPUY SUMMIT SIZE 2; PINNACLE ACETABULAR CUP SIZE 50; PINNACLE MTL INS NEUT36IDX50OD
-
-