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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNKNOWN HIP FEMORAL STEM

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DEPUY ORTHOPAEDICS INC US UNKNOWN HIP FEMORAL STEM Back to Search Results
Catalog Number UNK HIP FEMORAL STEM
Device Problems Loss of Osseointegration (2408); Device Dislodged or Dislocated (2923)
Patient Problems Unspecified Infection (1930); Necrosis (1971); Pain (1994); Joint Dislocation (2374); No Code Available (3191)
Event Date 07/20/2008
Event Type  Injury  
Manufacturer Narrative
Product complaint # (b)(4). Citing: the norwegian hip fracture register experiences after the first 2 years and 15,576 reported operations" by jan-erik gjertsen, lars b engesæter, ove furnes, leif ivar havelin, kjersti steindal, tarjei vinje, and jonas m fevang published online july 20, 2008 by acta orthopaedica 2008; 79 (5): 583¿593. (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
Literature article entitled "the norwegian hip fracture register experiences after the first 2 years and 15,576 reported operations" by jan-erik gjertsen, lars b engesæter, ove furnes, leif ivar havelin, kjersti steindal, tarjei vinje, and jonas m fevang published online july 20, 2008 by acta orthopaedica 2008; 79 (5): 583¿593 was reviewed for mdr reportability. "the norwegian hip fracture register was established in january 2005 to collect nationwide information as a basis for improved management of patients with hip fractures. The main aims of the hip fracture register are to collect epidemiological data, to evaluate the results of different treatment methods for the different types of hip fractures in various patient populations, and to identify inferior methods early on. The register also provides data on incidence of fracture types, treatment methods, and trends over time. Finally, hospital-specific results are reported back to the participating hospitals to facilitate improvement in treatment. This article is a report of the experience after the first 2 years. The information is comprised of 13,251 hips from 55 different hospitals and reports 2,325 hips received revision. Initial operations addressed various types of fractures and utilized various surgical procedures including fixations and hemiarthroplasty. The article reports of 4,669 screws or pins olmed (depuy) consisted of 2,710; out of 2,783 hemiarthroplasties depuy charnley(cemented), corail (uncemented) and titan (cemented) stems consisted of 1,571 - all were all noted as bipolar components. Reasons for revisions but unspecified to which products (both depuy and non depuy): sequelae of femoral neck fracture, osteosynthesis failure, nonunion, local pain due to osteosynthesis material through caput, dislocated hemiprosthesis, hematoma, superficial wound infection, fracture healed in wrong positon, sequelae of proximal femoral fracture (except femoral neck fracture) loosening of hemiarthroplasty, pain after hemiarthroplasty, other reasons and unknown. The total reasons were 2,619 indicating some of the 2,325 revisions entailed multiple reasonings.
 
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Brand NameUNKNOWN HIP FEMORAL STEM
Type of DeviceHIP FEMORAL STEM
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46582 0988
Manufacturer (Section G)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46582 0988
Manufacturer Contact
kara ditty-bovard
1210 ward avenue
west chester, PA 19380-0988
6107428552
MDR Report Key8909986
MDR Text Key158599461
Report Number1818910-2019-101608
Device Sequence Number1
Product Code KWY
Combination Product (y/n)N
Reporter Country CodeNO
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,l
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 08/11/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/20/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberUNK HIP FEMORAL STEM
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 Received08/27/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 08/20/2019 Patient Sequence Number: 1
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