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

Catalog Number UNK HIP FEMORAL STEM

Device Problems Loss of or Failure to Bond (1068); Osseointegration Problem (3003); Unintended Movement (3026); Migration (4003)

Patient Problems Ossification (1428); Pulmonary Embolism (1498); Arrhythmia (1721); Hematoma (1884); Thrombosis (2100); Impaired Healing (2378); Inadequate Osseointegration (2646); No Code Available (3191)

Event Date 12/01/2002

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, "ten to fifteen-year follow-up after total hip arthroplasty with a tapered cobalt-chromium femoral component (tri-lock) inserted without cement" written by marco a.Teloken, md, gina bissett, ba, william j.Hozack, md, peter f.Sharkey, md, and richard h.Rothman, md, phd published by the journal of bone and joint surgery, incorporated published december 2002 was reviewed.The article's purpose "to present the ten to fifteen-year results after primary total hip arthroplasty with use of this cobalt-chromium tapered femoral component inserted without cement." data was compiled from 41 men (50 hips) and 17 women (17 hips) receiving depuy hip implants between 1983 and 1986.The article reports the femoral stem was monoblock and was available only with a 32 mm head.Depuy products utilized: trilock monoblock femoral stems, cemented acetabular cups with poly liners (platforms not identified).Adverse event: deep being thrombosis (intervention not clarified), pulmonary embolism (intervention not clarified), cardiac arrhythmia (intervention not clarified), gout(intervention not clarified), hematomas(intervention not clarified), delayed wound healing(intervention not clarified), temporary femoral nerve injury(intervention not clarified).Loose cup accompanying osteolysis associated with poly wear (treated by revision), loose stem and subsidence (treated by revision), heterotopic ossification ((intervention not clarified).

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, a follow-up medwatch will be filed as appropriate.

• 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): JTE WARSAW MFG SITE; 700 orthopaedic drive; warsaw IN
• Manufacturer Contact: kara ditty-bovard ; 1210 ward avenue; west chester, PA 46581-0988 ; 6107428552
• MDR Report Key: 9452083
• MDR Text Key: 184947964
• Report Number: 1818910-2019-122384
• 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: 11/17/2019

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 STEM
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/17/2019
• Initial Date FDA Received: 12/11/2019
• Supplement Dates Manufacturer Received: 01/06/2020
• Supplement Dates FDA Received: 01/09/2020
• 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