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

Catalog Number UNK HIP FEMORAL STEM

Device Problem Loss of or Failure to Bond (1068)

Patient Problem No Code Available (3191)

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, "cellular mediators secreted by interfacial membranes obtained at revision total hip arthroplasty" written by arun s. Shanbhag, phd, joshua j. Jacobs, md, jonathan black, phd, jorge o. Galante, md, and tibor t. Glant, md, phd published by the journal of arthroplasty vol. 10 no. 4 1995 was reviewed. The article's purpose to report the cytokine/cellular mediator aspect from cemented and non cemented thas. It is noted that table 1 is a table of revisions and 3 cases are identified with depuy products. Each case is captured individually in linked complaints. Only stems are identified and they are all cemented with no further information provided regarding on the adverse events. Cement manufacturer not identified and specific loosening interface is not identified. This complaint captures cemented case 1 of (b)(6) male that received revision to aml stem for aseptic loosening.

• 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 ; 1210 ward avenue; west chester, IN 46581-0988 ; 6103142063
• MDR Report Key: 9417644
• MDR Text Key: 185196879
• Report Number: 1818910-2019-118658
• Device Sequence Number: 1
• Product Code: KXA
• Combination Product (Y/N): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: LITERATURE
• Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL
• Type of Report: Initial,Followup
• Report Date: 11/12/2019

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?: 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

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 01/03/2020
• 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 TREATMENT DATA

Date Received: 12/05/2019 Patient Sequence Number: 1