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 Pocket Erosion (2013)

Event Type  malfunction  

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.Investigation summary, no device was received.Root cause undetermined.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.(b)(4).

Event Description

"literature article entitled, ¿hydroxyapatite-coated versus grit-blasted femoral stems¿ by m.Hamadouche, et al, published by the journal of bone and joint surgery (2001), vol.83-b, pp.979-987, was reviewed.The aim of this prospective, randomized study was to evaluate the long-term stability of uncemented femoral components of the same design in two configurations, grit-blasted and hydroxyapatite-coated femoral stems in 50 hips implanted between may 1988-may 1990.Implanted depuy products: all patients were implanted with a profile stem, a trilock cup, a polyethylene liner, and a metal femoral head.Results: 1 hematoma treated with surgical evacuation.2 peroneal nerve palsies- treatment was unknown.The nerve palsies did not resolve completely.2 dislocations treated with closed reduction.1 recurrent dislocation secondary to a loosened cup- treated with cup revision.3 revisions of the cup and liner due to liner failure.In one, the liner fractured and in two the liner was worn through to the cup.In all 3 cases, the liner failure caused the head to articulate on the cup leading to intraoperatively identified metallosis and wear on the cup.The cup revision and metallosis was secondary to the liner failure.2 stems revised for loosening and stem migration.1 postoperative femoral fracture treated with orif and stem retention.10 intraoperative femoral fractures- 4 treated with cerclage.Radiographic findings: 29 cases of cortical hypertrophy, 10 mispositioned stems, 10 mispositioned stems, and 20 stem migrations.There were no patient consequences in the radiographically identified cases.Captured in this complaint: trilock cup: implant loosening/implant to bone.Polyethylene liner: implant fracture post op, implant bearing wear, implant dislocation.Femoral head: implant dislocation.Femoral stem: implant loosening, implant migration.Patient harms: hematoma, surgical intervention, medical device removal, joint dislocation, inadequate osseointegration, fracture, nerve injury.Femoral stem: implant migration, implant misposition.Patient harms: medical device site erosion.".

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 was received.Root cause undetermined.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may 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: 9451968
• MDR Text Key: 217439818
• Report Number: 1818910-2019-122370
• 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: 12/11/2019
• 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: 02/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1