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); Migration (4003)

Patient Problems Ossification (1428); Pulmonary Embolism (1498); Bone Fracture(s) (1870); Unspecified Infection (1930); Thrombosis (2100); 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, "single-stage, bilateral, cementless total hip arthroplasty" written by merrill a.Ritter, md, bradley k.Vaughn, md, facs, and laurence d.Frederick, md published by the journal of arthroplasty vol.10 no.2 1995 was reviewed.The article's purpose: review "the clinical and radiographic results of 92 patients who underwent single-stage, bilateral, cementless thas and specifically evaluated them clinically and radiographically for signs of failure." it is noted that depuy and non depuy products were utilized within the study.Procedures were performed between march 1984 and december 1989 with average of 54 years.The article does not identify which specific products are associated with the adverse events.The article does not provide adequate information to determine accurate quantities.Bearing surfaces not discussed within article.Depuy products utilized: srom stems, cementless aml stems, trilock stems; supercup, pca cups, mhp cups, anderson cups, cdh cups, aml cups, arthropore cups adverse events: intraoperative proximal femoral fracture (treatment not specified), peroneal nerve palsies (article specifies only one resolved), pulmonary embolus (treated by anticoagulation therapy), deep venous thrombosis (treated by anticoagulation therapy, revisions for the following reasons: infection, loose cup, subsidence and loosening of stem; radiographic findings of heterotopic ossification (impact to patient unknown).

• 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
• Manufacturer (Section G): JTE WARSAW MFG SITE; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer Contact: kara ditty-bovard ; 1210 ward avenue; west chester, IN 46581-0988 ; 6103142063
• MDR Report Key: 9445655
• MDR Text Key: 185342722
• Report Number: 1818910-2019-122054
• 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: 11/15/2019

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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/15/2019
• Initial Date FDA Received: 12/10/2019
• Supplement Dates Manufacturer Received: 01/13/2020
• Supplement Dates FDA Received: 01/14/2020
• 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