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

Catalog Number UNK HIP FEMORAL STEM

Device Problems Use of Device Problem (1670); Malposition of Device (2616); Migration (4003)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(6).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 will be filed as appropriate.(b)(4).

Event Description

Literature article entitled, ¿pros and cons¿ of total hip arthroplasty with metaphyseal proxima endoprosthesis¿ by waldemar wrazen, et al, published by klinika chirurgii urazowej ortopedii, 8 pages, was reviewed.The authors present their own experience concerning total hip arthroplasty with the metaphyseal prosthesis proxima between 2008-2013 using radiological and clinical follow-up of 1 year.The manufacturer of the acetabular components was no provided within the text of this study.The primary indication for tha implantation was unspecified degeneration of the hip from congenital diseases such as hip dysplasia or from post-traumatic osteoarthritis.Depuy implants: 62 proxima ultra-short femoral stems.Acetabular components and femoral head manufacturer are unknown.Results: 1 patient with a poor and 3 with a fair hhs- coded for pain.All patients experienced an increase in hip functionality.The authors note there were some patients who were unable to walk without assistance and/or had difficulty with adls.It is unknown if these outcomes were preexisting patient conditions or attributed to the tha- coded for medical device site joint range of motion decrease.7 mispositioned stems identified on progressive post-operative radiologic studies.4 stems migrated into valgus identified on progressive post-operative radiologic studies.7 stems migrated into varus identified on progressive post-operative radiologic studies.(b)(6) female implanted with proxima ultra-short femoral stem and acetabular components of unknown manufacturer.The stem was positioned incorrectly during seating due to a narrow natural femoral neck.The femoral stem migrated into valgus, identified on progressive radiographic studies.The authors attribute the device migration to the improper intraoperative positioning of the stem.The patient experienced no consequences and required no medical or surgical intervention.The authors note that the patient had good harris hip scores following index tha.

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.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, 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: 9324288
• MDR Text Key: 186722817
• Report Number: 1818910-2019-115562
• 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,literature
• Type of Report: Initial,Followup
• Report Date: 10/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2019
• Is this an Adverse Event Report?: No
• 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: 11/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 62 YR