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

Catalog Number UNK HIP FEMORAL STEM

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

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.

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.

• 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): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kara ditty-bovard ; 1210 ward avenue; west chester, PA 19380-0988 ; 6103142063
• MDR Report Key: 9378382
• MDR Text Key: 184737486
• Report Number: 1818910-2019-118154
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/26/2019
• 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: 12/12/2019
• 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