MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 SIGMA HP UNI FEMORAL SZ6 LM/RL; EARLY INTERVENTION : KNEE FEMORAL

Catalog Number 102407600

Device Problem Loose or Intermittent Connection (1371)

Patient Problems Pain (1994); Not Applicable (3189)

Event Date 05/25/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Patient has presented with a painful joint.Preoperative bone scans show increased uptake around the femoral component (hot).This appears to indicate a loose femoral component.On opening the knee surgeon found the medial facet of the unresurfaced patella to show evidence of cartilage wear due to articulation on the lateral edge of the femoral component.The femoral component was not overtly loose, but with gentle persuasion, the femoral component came away from the femur.It was believed that both the "loose" femur and the patella wear was the source of the pain.The femoral component was replaced with new one and the medial facet of the patella respected to reduce chance of impingement.

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, post market surveillance, or other events within the quality system.Device history lot : product code 102407600, lot number b1net4000.Device history review: dhr reviewed.Nr associated with record has nothing that would correlate to complaint.Nr reviewed by quality engineer.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: SIGMA HP UNI FEMORAL SZ6 LM/RL
• Type of Device: EARLY INTERVENTION : KNEE FEMORAL
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• Manufacturer (Section G): DEPUY RAYNHAM, A DIV. OF DEPUY ORTHO 1219655; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: kara ditty-bovard ; 1210 ward avenue; west chester, PA 19380-0988 ; 6103142063
• MDR Report Key: 7613740
• MDR Text Key: 111470750
• Report Number: 1818910-2018-62592
• Device Sequence Number: 1
• Product Code: HRY
• UDI-Device Identifier: 10603295001768
• UDI-Public: 10603295001768
• 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
• Report Date: 05/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/19/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 102407600
• Device Lot Number: B1NET4000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/18/2018
• Date Device Manufactured: 08/09/2007
• 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: 41 YR