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

Catalog Number UNK HIP FEMORAL HEAD

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Ossification (1428); Joint Dislocation (2374); Limited Mobility Of The Implanted Joint (2671); 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

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.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.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 will be filed as appropriate.

• Brand Name: UNKNOWN HIP FEMORAL HEAD
• Type of Device: HIP FEMORAL HEAD
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 9426099
• MDR Text Key: 173280963
• Report Number: 1818910-2019-121394
• 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: 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 HEAD
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention