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

Catalog Number UNK HIP FEMORAL STEM

Device Problems Loss of or Failure to Bond (1068); Device Dislodged or Dislocated (2923)

Patient Problems Unspecified Infection (1930); 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 reasoning.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provision of 21 cfr, part 803.The report may be based on the information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.H10 additional narrative: product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.A worldwide lot specific complaint database search, or device history record (dhr) review was not possible because the required lot code(s) was not provided.Based on previous investigations this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications.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.Corrective action was not indicated.Device history lot: null.Device history batch: null.Device history review: null.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: UNKNOWN HIP FEMORAL STEM
• Type of Device: HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 8909970
• MDR Text Key: 155488949
• Report Number: 1818910-2019-101603
• Device Sequence Number: 1
• Product Code: KXA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• 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 Received: 08/20/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK HIP FEMORAL STEM
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/27/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention