• 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 UNKNOWN HIP 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 UNKNOWN HIP ACETABULAR LINERS Back to Search Results
Catalog Number UNK HIP ACETABULAR LINER
Device Problem Naturally Worn (2988)
Patient Problems Edema (1820); Foreign Body Reaction (1868); Hypersensitivity/Allergic reaction (1907); Pain (1994); Pocket Erosion (2013); Injury (2348); Osteolysis (2377); Test Result (2695); No Code Available (3191)
Event Date 10/17/2018
Event Type  Injury  
Manufacturer Narrative
(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.
 
Event Description
Pcf and medical records received. After review of medical records, patient was revised to address adverse local tissue reaction with metallosis after right total hip arthroplasty with significant lysis and greater trochanteric fracture along with pseudotumor. Operative notes stated that radiographs showed osteolysis and lucency under acetabular shell as well as elevated esr and crp. An aspiration of the hip revealed white blood cell count greater than 6000 as well as a left shift. A ct scan showed possibility of pseudotumor and elevated cobalt and chromium levels. Incision was made laterally, dissected down to the iliotibial band to gluteus medius vastus lateralis and found obvious greater trochanteric fracture that was comminuted as well as loss of the calcar when the stem was examined. There was a tremendous amount of metal stained tissue. The bone also appeared stained with metal debris. When the head was removed , the trunnion was exposed with significant amount of metal oasis. Attention was in acetabular component, significant amount of anteversion was noted. There was a large area of pseudotumor and was excised. There was also a fluid on the hip. There was a significant erosion of the acetabulum with loss of mainly the anterior wall. No indication of infection. There was significant amount of posterior impingement noted and the trunnion of the femoral stem had been impinge posteriorly on the cup for many years. Doi: (b)(6) 2008; dor: (b)(6) 2018 right hip.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameUNKNOWN HIP ACETABULAR LINERS
Type of DeviceHIP ACETABULAR LINERS
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 drive
warsaw, IN 46581-0988
6107428552
MDR Report Key9792953
MDR Text Key187546936
Report Number1818910-2020-06921
Device Sequence Number1
Product Code KWY
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
Report Date 02/18/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/05/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberUNK HIP ACETABULAR LINER
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 Received03/23/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 03/05/2020 Patient Sequence Number: 1
-
-