MAUDE Adverse Event Report: DEPUY IRELAND 961610 PFC*SIGMA/OV/DOME PAT 3PEG,38; SIGMA KNEE PRIMARY : KNEE PATELLA

Catalog Number 960102

Device Problem Insufficient Information (3190)

Patient Problems Unspecified Infection (1930); Pain (1994)

Event Date 03/01/2018

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

The patient was revised to address pain.The patient was tested for infection.The results were positive.Implants removed and revision implants were implanted.Doi: unk; dor: (b)(6) 2018; right knee.

Manufacturer Narrative

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.

• Type of Device: SIGMA KNEE PRIMARY : KNEE PATELLA
• Manufacturer (Section D): DEPUY IRELAND 961610 ; 700 orthopaedic drive; warsaw IN 46582 0988
• Manufacturer (Section G): DEPUY IRELAND 961610 ; loughbeg ringaskiddy; cork IN ; EI
• Manufacturer Contact: chad gibson ; 700 orthopaedic drive; warsaw, IN 46582-0988 ; 5743725905
• MDR Report Key: 7365260
• MDR Text Key: 103294189
• Report Number: 1818910-2018-55964
• Device Sequence Number: 1
• Product Code: HWA
• UDI-Device Identifier: 10603295232629
• UDI-Public: 10603295232629
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K961685
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 03/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 960102
• Device Lot Number: 8581734
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/18/2018
• Date Device Manufactured: 07/19/2017
• 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: 43 YR
• Patient Weight: 158