• 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 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. 1818910 PINNACLE MTL INS NEUT36IDX50OD PINNACLE HIP SYSTEM : HIP METAL ACETABULAR LINERS Back to Search Results
Catalog Number 121887350
Device Problems Naturally Worn (2988); Appropriate Term/Code Not Available (3191)
Patient Problems Host-Tissue Reaction (1297); Unspecified Infection (1930); Itching Sensation (1943); Necrosis (1971); Neuropathy (1983); Pain (1994); Loss of Range of Motion (2032); Rash (2033); Sepsis (2067); Tissue Damage (2104); Anxiety (2328); Discomfort (2330); Injury (2348); Depression (2361); Osteolysis (2377); Limited Mobility Of The Implanted Joint (2671); Test Result (2695); Not Applicable (3189); No Code Available (3191)
Event Date 04/27/2018
Event Type  Injury  
Manufacturer Narrative
(b)(4). If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate. (b)(6).
 
Event Description
Pinnacle litigation records received. Litigation alleges toxic cobalt-chromium metal debris to be released into patient's soft tissue surrounding the implant. The patient began to have difficulty with normal everyday tasks, experienced extreme pain, difference in leg length made walking difficulty and there was also a grinding sensation present while walking. Sitting and standing caused her extreme discomfort. The surgeon informed her that she had elevated metal ions. During revision surgery it was discovered that the implant had caused significant metallosis in the soft tissues and blackened discolored tissue throughout the hip. Doi: (b)(6) 2007: dor: (b)(6) 2018 (right hip).
 
Manufacturer Narrative
Investigation summary: no device associated with this report was received for examination. The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system. Depuy considers the investigation closed. Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary. If information is obtained that was not available for the initial medwatch , a follow-up medwatch, a follow-up medwatch will be filed as appropriate.  .
 
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. 1818910
700 orthopaedic drive
warsaw IN 46582 0988
Manufacturer (Section G)
DEPUY ORTHOPAEDICS, INC. 1818910
700 orthopaedic dr.
warsaw IN 46581 0988
Manufacturer Contact
kara ditty-bovard
1210 ward avenue
west chester, PA 19380-0988
6103142063
MDR Report Key7822021
MDR Text Key118395437
Report Number1818910-2018-67832
Device Sequence Number1
Product Code KWA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K062426
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,Followup
Report Date 08/03/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/28/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date09/30/2012
Device Catalogue Number121887350
Device Lot Number2452980
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 Received12/02/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/03/2007
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: 08/28/2018 Patient Sequence Number: 1
-
-