MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 PRESERVATION UNI FEM CEM SZ4; EARLY INTERVENTION : KNEE FEMORAL

Catalog Number 149801004

Device Problems Use of Device Problem (1670); Positioning Problem (3009)

Patient Problems Pain (1994); Loss of Range of Motion (2032); Swelling (2091); No Code Available (3191)

Event Date 03/11/2019

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.Device was used for treatment, not diagnosis.(b)(4).

Event Description

Patient underwent a left uni knee replacement on 2004.On (b)(6) 2019, the patient presented for an evaluation for left knee pain, decreased range of motion, stiffness, and grinding.An x-ray image revealed bowing of the femur in varus alignment.The all poly tray looked good.The patient had developed lateral compartment degenerative joint disease and patellofemoral degenerative joint disease.It is noted the patient has an attune total knee replacement on the right side.The x-ray revealed no issues with the right knee.There are no allegations involving the right knee.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provision of 21 cfr, part 803.The report may be based on the information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Product complaint #: (b)(4).Investigation summary: no device associated with this report was received for examination.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.Device history lot: null.Device history batch: null.Device history review: null.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: PRESERVATION UNI FEM CEM SZ4
• Type of Device: EARLY INTERVENTION : KNEE FEMORAL
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 8482827
• MDR Text Key: 140909922
• Report Number: 1818910-2019-89731
• Device Sequence Number: 1
• Product Code: HRY
• Combination Product (y/n): N
• PMA/PMN Number: K010810
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 03/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 149801004
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/01/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 70 YR
• Patient Weight: 116