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

Catalog Number UNK HIP ACETABULAR LINER

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pulmonary Embolism (1498); Stroke/CVA (1770); Myocardial Infarction (1969); Pain (1994); Respiratory Tract Infection (2420); No Code Available (3191)

Event Date 01/08/2009

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.Investigation summary.No device associated with this report was received for examination.A worldwide lot specific complaint database search, or device history record (dhr) review was not possible because the required lot code(s) was not provided.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Corrective action was not indicated.(b)(4).

Event Description

"literature article entitled, ¿large diameter femoral head uncemented total hip replacement to treat fractured neck of femur¿ by a.J.Barnett, et al, published by injury: international journal for the care of the injured (2009), vol.40, pp.752-755, was reviewed.The aim of this study was to investigate the use of large diameter head thr to treat fractured neck of femur, and to demonstrate if this conferred greater stability in 46 patients implanted between april 2005 and december 2007.Implanted depuy products: all patients were implanted with a pinnacle cup, unknown depuy liner, 36-mm femoral head, and a corail stem.Results: there were no revisions or reoperations noted in this study.2 deaths from causes unrelated to the implants or the surgical procedure.1 postoperative hematoma secondary to long-term warfarin used to treat a mechanical heart valve- no surgical evacuation required.This event is not attributed to the surgical procedure or the implanted components.3 intraoperative calcar fractures- 1 treated with cerclage.1 upper respiratory tract infection in a patient with a history of bronchiectasis- treated with antibiotics.1 intraoperative myocardial infarction.The patient received a coronary artery bypass one-month postoperatively and made a full recovery.2 pulmonary emboli treated with warfarin.1 cerebrovascular accident 5 days postoperatively causing right-side weakness and impaired mobility- no treatment information was provided.1 case of chronic back pain causing limited mobility- no treatment specified.1 case of trochanteric bursitis and pain- no treatment specified.Captured in this complaint: pinnacle cup, acetabular liner, femoral head, and corail stem: no reported product problem.Patient harms: pulmonary embolism, myocardial infarction, cva, infection, upper respiratory tract, pain, bursitis, walking difficulty, weakness, fracture.".

• Brand Name: UNKNOWN HIP ACETABULAR LINERS
• Type of Device: HIP ACETABULAR LINERS
• 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 ; 700 orthopaedic drive; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 9417982
• MDR Text Key: 185224063
• Report Number: 1818910-2019-120923
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK HIP ACETABULAR LINER
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/14/2019
• 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