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

Catalog Number UNK HIP FEMORAL STEM

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

Patient Problems Unspecified Infection (1930); No Code Available (3191)

Event Date 08/13/2003

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, ¿wear of ultra-high-molecular-weight polyethylene cup articulating with 22.225 mm zirconia diameter head in cemented total hip arthroplasty¿ by michael wroblewski, et al, published by journal of orthopaedic science (2004), vol.9, pp.253-255, was reviewed.The authors present their experience with a 22.225mm diameter zirconia head on a 9¿10 taper articulating with an ultra-high-molecular-weight polyethylene (uhmwpe) cup in 339 cemented total hip arthroplasties.The thas used in this study included an unknown polyethylene cup, a competitor zirconia femoral head, and depuy cement and femoral stem.Implanted depuy products: c-stem femoral stem.All cups and stems were cemented with depuy cmw cement.Results: 1 total hip revision due to infection.4 unknown cups cemented with depuy cmw cement were identified as loose on progressive radiological studies over 2 years- no revision or intervention required.1 periprosthetic femoral fracture sustained during an unspecified trauma.The fracture was not attributed to the c-stem or the cmw cement and is therefore not included in this complaint.Captured in this complaint: 1 c-stem: no reported product problem.4 cmw cement: implant loosening of an unknown interface.Patient harms: infection, medical device removal, surgical intervention.".

• 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 46582
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic drive; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 9415798
• MDR Text Key: 169236057
• Report Number: 1818910-2019-120601
• Device Sequence Number: 1
• Product Code: KXA
• 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: 11/13/2019

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 FEMORAL STEM
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/13/2019
• 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