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 Hematoma (1884); Joint Dislocation (2374); No Code Available (3191)

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.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.".

• 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
• Manufacturer (Section G): JTE WARSAW MFG SITE; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic drive; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 9451941
• MDR Text Key: 185232067
• Report Number: 1818910-2019-122366
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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
• 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?: 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/17/2019
• 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