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

Catalog Number UNK HIP FEMORAL AUGMENT

Device Problems Loss of Osseointegration (2408); Osseointegration Problem (3003); Unintended Movement (3026); Migration (4003)

Patient Problems Bone Fracture(s) (1870); Pain (1994); Injury (2348); Inadequate Osseointegration (2646); 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.(b)(4).

Event Description

The literature article entitled, "comparison of a hydroxyapatite-coated sleeve and a porous-coated sleeve with a modular revision hip stem" written by michael p.Bolognese, md, ricardo pietrobon, md, phd, phillip e.Clifford, md and t.Parker vail, md published by the journal of bone and joint surgery, incorporated was reviewed.The article's purpose was to compare the performance of a hydroxyapatite-coated proximal sleeve and a porous bead-coated sleeve in patients managed with a modular revision hip system.Data was compiled from fifty-two patients implanted with srom hip implant system between august 1992 and december 1996 with clinical and radiographic follow ups at three months, six months, and yearly for a minimum of two years (range 2 to 7.5 years).Depuy products utilized: srom hip implant system, bearings not identified.Adverse events: subsidence and loosening (treated by revision), pain (treated by revision), recurrent dislocations (treated by revision and exchange of head and liner), intraoperative femur fractures during implantation (treated by cerclage wiring), calcar remodeling changes (radiographic findings), heterotopic ossification (radiographic findings), pedestal formations (radiographic findings).The article does not provide any information on interventions for radiographic findings.The article does not provide adequate information to determine accurate quantities.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provision depuy synthes 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.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 AUGMENT
• Type of Device: HIP FEMORAL AUGMENT
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 9378429
• MDR Text Key: 185037100
• Report Number: 1818910-2019-118157
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Type of Report: Initial,Followup
• Report Date: 11/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK HIP FEMORAL AUGMENT
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/07/2019
• Initial Date FDA Received: 11/26/2019
• Supplement Dates Manufacturer Received: 12/12/2019
• Supplement Dates FDA Received: 12/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention