• 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 NEUT36IDX54OD 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 NEUT36IDX54OD PINNACLE HIP SYSTEM : HIP METAL ACETABULAR LINERS Back to Search Results
Model Number 1218-87-354
Device Problems Difficult to Remove (1528); Device Dislodged or Dislocated (2923); Naturally Worn (2988)
Patient Problems Muscular Rigidity (1968); Pain (1994); Joint Dislocation (2374); Osteolysis (2377); Joint Laxity (4526); Unspecified Tissue Injury (4559); Swelling/ Edema (4577)
Event Date 10/01/2021
Event Type  Injury  
Manufacturer Narrative
Product complaint # (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
Subject id: (b)(6). Study: (b)(6). Clinical notification received for revision of right total hip to address dislocation date of implantation: (b)(6) 2010. Date of revision: (b)(6) 2021. (right hip). Treatment: revision of cup, hole eliminator, liner, and head.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NamePINNACLE MTL INS NEUT36IDX54OD
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 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 Key12646389
MDR Text Key276837901
Report Number1818910-2021-22841
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 Study,Health Professional
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup
Report Date 10/08/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/18/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number1218-87-354
Device Catalogue Number121887354
Device Lot Number3130835
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/30/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/14/2010
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 10/18/2021 Patient Sequence Number: 1
Treatment
APEX HOLE ELIM POSITIVE STOP; PINNACLE 100 ACET CUP 54MM; PINNACLE MTL INS NEUT36IDX54OD; S-ROM M HEAD 36MM +3; S-ROM*SLEEVE PRX ZTT, 18D-LRG; SROM STM STD 36+12L 13X18
-
-