MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 SIGMA POR TRAY SCREW 6.5/35MM; BONE SCREWS AND PINS : KNEE TIBIAL TRAY ACCESSORY

Catalog Number 875704

Device Problem Failure To Adhere Or Bond (1031)

Patient Problem Pain (1994)

Event Date 02/07/2018

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 knee pain in the total knee.It was stated that, there was no patella in the patient from the first surgery.Bone scan was hot around the tibia.It was decided by the doctor that the tibia was loose at the bone to implant interface.Pressfit sigma fb tibia was pulled out and a sigma fixed bearing cemented tibia with a stem replaced the pressfit one.The patella was resurfaced at this time as well.Doi: (b)(6) 2016, dor: (b)(6) 2018, right knee.

Manufacturer Narrative

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

• Brand Name: SIGMA POR TRAY SCREW 6.5/35MM
• Type of Device: BONE SCREWS AND PINS : KNEE TIBIAL TRAY ACCESSORY
• 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: chad gibson ; 700 orthopaedic drive; warsaw, IN 46582-0988 ; 5743725905
• MDR Report Key: 7298840
• MDR Text Key: 101012101
• Report Number: 1818910-2018-54137
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 10603295218685
• UDI-Public: 10603295218685
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K983015
• 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: 02/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2018
• Device Catalogue Number: 875704
• Device Lot Number: 436402
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/13/2018
• Date Device Manufactured: 11/26/2013
• 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: 74 YR
• Patient Weight: 97