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); Migration (4003)

Patient Problems Ossification (1428); Bone Fracture(s) (1870); No Code Available (3191)

Event Date 01/21/2015

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

"literature article entitled, ¿acute revision hip arthroplasty: a previously unrecognized risk factor for heterotopic ossification¿ by abdulaziz aljurayyan, et al, published by european journal of orthopaedic surgical traumatology (2016), vol.26, pp.183-188, was reviewed.The aim of this retrospective review was to determine the incidence and severity of heterotrophic ossification (ho) following acute revision total hip arthroplasty (tha), and whether this represents a significant risk factor for ho that should be treated prophylactically.This study includes depuy products paired with competitor products.The authors review the findings for a total of seven patients.There is insufficient information to determine which manufactured products were used in each patient.The number of depuy products associated with the results of this study are unknown.Implanted depuy products: 3 pinnacle cups, 3 s-rom femoral stems and sleeves, 1 trilock femoral stem, and 1 solution femoral stem.The authors do not provide information on the acetabular liners or femoral heads.It is assumed that there were 3 pinnacle liners and 5 unknown depuy femoral heads used in the study.Depuy and competitor products were paired in several patients.Results: 1 dislocation treated with revision of unknown components.1 postoperative femoral fracture secondary to stem migration treated with revision of the stem.1 postoperative acetabular fracture secondary to a dislocation and mispositioned cup treated with cup revision.2 s-rom femoral stem revisions due to instability secondary to a mispositioned stem.The femoral sleeves were well-fixed and left in situ.The stem and head were revised to correct the femoral offset.1 impingement secondary to a dislocation treated with surgical arthrotomy and excision of the ischium to correct the impingement.The devices were retained.7 cases of heterotopic ossification and pain ranging in severity from severe to mild.The authors indicate that the above reoperations were causative factors in the development of the ossification.The treatment was late irradiation to prevent progression of the ossification.Captured in this complaint: implant migration, implant misposition.Acetabular liner: implant dislocation.Femoral head: implant dislocation.Femoral stem: implant misposition, implant migration.Femoral sleeve: implant misposition, implant migration.Patient harms: surgical intervention, medical device removal, medical device site joint movement impairment, joint instability, joint dislocation, fracture, extraskeletal ossification.".

Manufacturer Narrative

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 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
• Manufacturer (Section G): JTE WARSAW MFG SITE; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer Contact: kara ditty-bovard ; 1210 ward avenue; west chester, PA 19380-0988 ; 6107428552
• MDR Report Key: 9426138
• MDR Text Key: 185494324
• Report Number: 1818910-2019-121395
• Device Sequence Number: 1
• Product Code: KXA
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/17/2019

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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/03/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention