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

Catalog Number UNK HIP ACETABULAR CUP

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

Patient Problems Unspecified Infection (1930); Pain (1994); Not Applicable (3189); No Code Available (3191)

Event Date 01/01/2004

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, "thigh pain in primary total hip arthroplasty" written by carlos lavernia, md, michele d'apuzzo, md, victor hernandez, md, and david lee, phd published by the journal of arthroplasty vol. 19 no. 7 suppl. 2 2004 was reviewed. The article's purpose to assess the effects of material composition in the development of thigh pain after primary cementless total hip arthroplasty in a tapered stem series. Data was compiled from 241 patients who received depuy tha products between november 1997 and june 2001. All components were press-fitted and cups had supplemental fixation screws with poly liners. All stems were trilock stems that were cobalt-chrome-molybdenum prior to 2000 and titanium-aluminum-vanadium in year 2000 and after. Patients age range 18-93 and were followed for a minimum of 2 years. Depuy products utilized: trilock stems, femoral head, poly liner, pressfit cup, cup fixation screws. Adverse events: infection (treated with revision), periprosthetic femur fracture (treatment not clarified), thigh pain (treatment not clarified), stems in valgus or varus positions (treatment not clarified), pedestal formations in femur(treatment not clarified) the article does not provide adequate information to determine accurate quantities.

Manufacturer Narrative

(b)(4) to capture medical device removal.

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.

• 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
• Manufacturer (Section G): JTE WARSAW MFG SITE; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer Contact: kara ditty-bovard ; 1210 ward avenue; west chester, PA 19380-0988 ; 6107428552
• MDR Report Key: 9397322
• MDR Text Key: 185216816
• Report Number: 1818910-2019-119100
• Device Sequence Number: 1
• Product Code: KWA
• 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,Followup
• Report Date: 11/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Catalogue Number: UNK HIP ACETABULAR CUP
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 12/12/2019
• 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 Treatment Data

Date Received: 12/02/2019 Patient Sequence Number: 1