• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 PINNACLE MTL INS NEUT40IDX60OD 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 INTERNATIONAL LTD - 8010379 PINNACLE MTL INS NEUT40IDX60OD PINNACLE HIP SYSTEM : HIP METAL ACETABULAR LINERS Back to Search Results
Model Number 1218-87-460
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Adhesion(s) (1695); Edema (1820); Hypersensitivity/Allergic reaction (1907); Necrosis (1971); Pain (1994); Synovitis (2094); Tissue Damage (2104); No Code Available (3191)
Event Date 01/14/2020
Event Type  Injury  
Manufacturer Narrative
(b)(4). A follow up will be conducted to provide the legal plaintiff information for the initial reporter once the details are provided. (b)(4). If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
Event Description
Medical records received. After review of medical records, it was indicated that patient mri showed some deterioration within the joint. The patient was then revised for failed right total hip. Operative notes reported that as soon as surgery went through capsule, there was a black fluid that came out. Surgeon went and remove some synovium, but everything was pretty much degenerated. Send some synovium and necrotic tissue to pathology. Surgeon then cleared as much of the scar tissue from around the hip. Surgeon removed a lot of necrotic sort o amorphous tissue typical of what we seen a metal reaction and there was a fair amount of brownish tinged fluid that is filled out when we opened the hip capsule. Head and liner were revised. Mri reported of pain, synovitis and osteolysis lab results for cocr level were below 7 ppb doi: (b)(6) 2008; dor: (b)(6) 2020; right hip.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NamePINNACLE MTL INS NEUT40IDX60OD
Type of DevicePINNACLE HIP SYSTEM : HIP METAL ACETABULAR LINERS
Manufacturer (Section D)
DEPUY INTERNATIONAL LTD - 8010379
st. anthony's road
leeds LS11 8DT
UK LS11 8DT
Manufacturer (Section G)
DEPUY INT'L LTD. 8010379
st anthonys road
leeds LS11 8 DT
UK LS11 8 DT
Manufacturer Contact
kara ditty-bovard
700 orthopaedic dr.
warsaw, IN 46581-0988
6107428552
MDR Report Key10600006
MDR Text Key208970209
Report Number1818910-2020-21066
Device Sequence Number1
Product Code KWA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K06242
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,health professional
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 09/15/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/29/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date10/31/2012
Device Model Number1218-87-460
Device Catalogue Number121887460
Device Lot Number2484613
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/04/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/02/2007
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: 09/29/2020 Patient Sequence Number: 1
Treatment
12/14 ARTICUL 40MM M SPEC+5; CORAIL2 NON COL HO SIZE 15; PINNACLE 100 ACET CUP 60MM
-
-