MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 UNKNOWN HIP FEMORAL STEM

Catalog Number UNK HIP FEMORAL STEM

Device Problems Loss of or Failure to Bond (1068); Migration (4003)

Patient Problems Bone Fracture(s) (1870); No Code Available (3191)

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.Device was used for treatment, not diagnosis.Concomitant medical products: unknown hip femoral head, unknown bone cement (manufacturer unidentified).(b)(4).

Event Description

A literature article was received entitled: "the premature failure of the charnley elite-plus stem: a confirmation of rsa predictions¿, by j.Hauptfleisch, et.Al, published in j bone joint surg [br] 2006; 88-b: 179-83.Authors did a 10 year follow-up of depuy charnley elite-plus femoral stem using rsa (a roentgen stereophotogram-metric analysis) to evaluate femoral stem migration and rotation, in the attempt to observe what factors are predictive of femoral stem loosening.Authors found that the elite-plus stem suffered less subsidence than previous generation depuy charnley monobloc devices presented in past studies.But this elite-plus stem suffered a greater incidence of internal rotation leading to posterior head migration and stem loosening.Authors stated that all patients had depuy elite-plus femoral stems (19 of which were modified with rsa tracking), with 28 mm femoral heads, paired with cemented charley lpw or ogee all-polyethylene cemented acetabular cups.Cement manufacturer was not specified.Results: out of 118 patients, 18 patients died (no suggestion that these deaths were at all device related) and seven were lost to follow-up.Of the remaining patients, aseptic loosening of the acetabular cup resulting in revision occurred in one hip (interface unspecified).Failure due to aseptic loosening of the stem (interface unspecified) occurred in 14 patients.Of these 14, 11 had hip revision surgery for loosening of the femoral stem, one was revised for a periprosthetic femur fracture, one patient died awaiting revision (no suggestion that the devices contributed to the death), and one patient refused revision surgery.

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.Depuy considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.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. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 8793349
• MDR Text Key: 151154776
• Report Number: 1818910-2019-98441
• 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: 06/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/16/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK HIP FEMORAL STEM
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention