MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNKNOWN HIP ACETABULAR CUP

Catalog Number UNK HIP ACETABULAR CUP

Device Problems Loss of or Failure to Bond (1068); Device Dislodged or Dislocated (2923)

Patient Problems Pain (1994); Skin Irritation (2076); Injury (2348); Joint Dislocation (2374); Impaired Healing (2378); 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, "hip prosthesis of antibiotic loaded acrylic cement for the treatment of infections following total hip arthroplasty" written by steven j.Wentworth, bs, bassam a.Masri, md, clive p.Duncan, md, and carleton b.Southworth, ba, ms published by the journal of bone and joint surgery incorporated (2002) was reviewed.The article's purpose was to "report the results of a retrospective study of 135 patients who were treated with the prostalac hip implant by five orthopaedic surgeons at the university of (b)(6), between november 1989 and september 1998.The study compared these data with those in the published literature regarding the results of two stage exchange arthroplasty for the treatment of infection at the site of a total hip replacement." data was compiled from 66 males (ages 27-86 years) and 59 females (ages 32-87).Tables within the article provide summaries of complications and adverse events at first stage and second stage utilizing the prostalac products.The article notes there were 6 deaths captured in a table but they were unrelated to the product clarified in narrative description.The article does not clarify the original implants or the revision implants utilized during the 2nd stage.Table v associates adverse events and complications with prostalac for patients who retained their prostalac products as their permanent hip prosthesis so those adverse events are captured with the same impacted product.The article does not provide adequate information to determine accurate quantities of product as more than one adverse event can be experienced by a patient.Depuy products utilized: prostalac stem, femoral head, prostalac cup, prostalac cement.Adverse events associated with prostalac in 1st stage with unknown interventions and no detail provided: intraoperative bone fracture, dislocation, wound healing delay, femur perforated, component insert difficulty, component loosening, cement fracture, pain, perforated acetabulum.Adverse events associated with prostalac in 1st stage with known interventions: re-current infection (treated by reimplantation of new prostalac products), dermatological reaction (treated by oral and topical steroids successfully).Adverse events associated with prostalac during 2nd stage for those patients who retained prostalac products as their prosthesis without indication of intervention: dislocation, recurrent infection, delayed wound healing, intraoperative bone fracture, post operative bone fracture, component loosening (not specified), cement fracture, cement extrusion.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions 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.H10 additional narrative: corrected: h6.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, a follow-up medwatch will be filed as appropriate.

• Brand Name: UNKNOWN HIP ACETABULAR CUP
• Type of Device: HIP ACETABULAR CUP
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 9466991
• MDR Text Key: 185775151
• Report Number: 1818910-2019-120500
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Type of Report: Initial,Followup
• Report Date: 11/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK HIP ACETABULAR CUP
• 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