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

Catalog Number UNK HIP FEMORAL STEM

Device Problems Loss of Osseointegration (2408); Device Dislodged or Dislocated (2923); Osseointegration Problem (3003)

Patient Problems Ossification (1428); Pulmonary Embolism (1498); Bone Fracture(s) (1870); Pain (1994); Joint Dislocation (2374); Inadequate Osseointegration (2646); No Code Available (3191)

Event Date 02/01/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).  if information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.(b)(4).

Event Description

The literature article entitled, "long-term results of use of the anatomic medullary locking prosthesis in total hip arthroplasty" written by c.Anderson engh, jr, md, william j.Culpepper, ii, md and charles a.Engh, md published by the journal of bone and joint surgery, incorporated (1997) was reviewed.The article's purpose was to report upon the clinical and radiographic results of 233 consecutive primary hip arthroplasties in 215 patients before january 1985 with the aml prosthesis.The article does not provided adequate information to determine accurate quantities of impacted products.Depuy products utilized: aml monoblock cementless, poly liner, cocr cup.Adverse events: thigh pain (associated with loose femoral stem and treated by revision - femoral components and liner were exchanged), infection (treated by revision and all components explanted and replaced), recurrent dislocations (treated by revision), loose cups (treated by revision), osteolysis (associated with poly liner wear) in acetabulum and migration of cup (treated by revision), hetero-topic ossification leading to re-hospitalization (no further information provided), intra operative femoral fracture (resulting in extended hospital stay and treated intraoperatively with plate), pulmonary embolism (no interventions indicated), general reports of pain without root cause.

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: added: h6(device code).Product complaint (b)(4).Investigation summary: no device associated with this report was received for examination.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.Depuy considers the investigation closed.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 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 46581 0988
• MDR Report Key: 9426232
• MDR Text Key: 185231130
• Report Number: 1818910-2019-121402
• 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: health professional,literatur
• Type of Report: Initial,Followup
• Report Date: 11/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2019
• 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: 01/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention