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

Catalog Number UNK HIP FEMORAL STEM

Device Problem Loss of or Failure to Bond (1068)

Patient Problems No Consequences Or Impact To Patient (2199); Inadequate Osseointegration (2646)

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

Literature article entitled: ¿fracture of the c-stem cemented femoral component in revision hip surgery using bone impaction grafting technique: report of 9 cases¿, by martín buttaro et al., published online by hip int 2015; 25(2): 184-187 doi: 10.5301/hipint.5000210, 03 feb 2015 was reviewed for mdr reportability on 06/10/2019.The purpose of this paper was to look at fracture of the c-stem cemented femoral component in revision hip surgery using bone impaction grafting technique from 2006 to 2013.There were 6 long stems and 3 conventional stems that fractured.Two of the 9 cases had been previously operated on in another institution and that information is not in this paper.There were 6 males and 3 females, with an average age of 65 years.Original diagnosis was osteoarthritis in 7 cases, developmental dysplasia of the hip in 1 case and rheumatoid arthritis in 1 case.Revision diagnosis prior to the stem fracture was aseptic loosening in 5 cases, a previous stem fracture in 2 cases, an osteosynthesis plate fracture after a periprosthetic fracture in 1 case and a periprosthetic fracture in 1 case.Bone allografts from frozen femoral heads were utilized, as well as cmw1 with gentamicin cement.The paper noted that in a series of 621 c-stem cases, 34 revision occurring after the average 13-year follow-up due to loosening, 2 were associated with stem fracture.The stem had caught the trochanteric wire at the time of stem insertion creating a defect in the proximal cement mantle.This problem is said to relate to surgical technique rather than implant design.This pc is being created to report the malfunctions and serious injuries noted in this paper for the patient's with c-stem implants that do not have patient identifiers attached (general).

Manufacturer Narrative

[(b)(4) lit article 11 jun 2019 (1).Pdf].

Manufacturer Narrative

Product complaint #
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> (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on 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.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on 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.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 number 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.If information is obtained that was not available for the initial medwatch, a follow-up 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: 8749511
• MDR Text Key: 149679008
• Report Number: 1818910-2019-97259
• Device Sequence Number: 1
• Product Code: KWY
• 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,Followup,Followup
• Report Date: 06/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 06/11/2019
• Initial Date FDA Received: 07/01/2019
• Supplement Dates Manufacturer Received: 06/11/2019; 06/11/2019; 07/12/2019
• Supplement Dates FDA Received: 07/01/2019; 07/10/2019; 07/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention