MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 SIGMA HP UNI FEMORAL SZ5 RM/LL; KNEE FEMORAL COMPONENT

Catalog Number 102408500

Device Problem Insufficient Information (3190)

Patient Problem Pain (1994)

Event Date 10/30/2017

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.

Event Description

The patient was revised to address pain.

Manufacturer Narrative

If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.This complaint is still under investigation.Depuy will notify the fda of the results of this investigation once it has been completed.

Event Description

Additional information received indicating that reason for revision was due to arthritis extension.No components were loose.No other significant patient factors were implicated.

Manufacturer Narrative

This product was reported in error.No patient death, serious injury or evidence of reportable product malfunction occurred.Depuy considers the investigation closed at this time.Should any additional information be received to change the outcome of the performed investigation, the complaint will be re-opened.

• Brand Name: SIGMA HP UNI FEMORAL SZ5 RM/LL
• Type of Device: KNEE FEMORAL COMPONENT
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46582
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer Contact: chad gibson ; 700 orthopaedic drive; warsaw, IN 46582 ; 5743725905
• MDR Report Key: 7058101
• MDR Text Key: 92898329
• Report Number: 1818910-2017-50197
• Device Sequence Number: 1
• Product Code: HRY
• UDI-Device Identifier: 10603295001812
• UDI-Public: 10603295001812
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K070849
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 10/30/2017

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: 102408500
• Device Lot Number: 190827
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/31/2017
• Initial Date FDA Received: 11/25/2017
• Supplement Dates Manufacturer Received: 10/30/2017; 11/09/2017; 01/25/2018
• Supplement Dates FDA Received: 11/26/2017; 12/15/2017; 01/25/2018
• Date Device Manufactured: 01/31/2012
• 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
• Patient Age: 55 YR