MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 UNKNOWN KNEE TIBIAL TRAY

Catalog Number UNK KNEE TIBIAL TRAY

Device Problem Use of Device Problem (1670)

Patient Problems Pain (1994); No Code Available (3191)

Event Date 03/01/2019

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.This report is for an unknown device/unknown lot.Part and lot number are unknown; udi number is unknown.(b)(4).

Event Description

The primary surgery was performed on (b)(6) 2019 via tka by using attune ps fixed (the ps femour #6, the fixed tibia #6, the ps fixed insert #6, the 7mm patella 38mm).The surgeon recognized at ct that the tibial insert was dissociated in the anterior direction and the patella was cracked when the patient visited to the hospital and complained the pain on (b)(6) 2019.Thus, the revision surgery was scheduled to be performed on (b)(6) 2019.It was planning to replace the tibial insert to thin insert, and to wiring and pinning the patella or replace according the situation of the patella.The surgeon commented that it would be considered as cause of the patella was cracked and the insert was dissociated because the patella pressure was high and also the knee was tight in flexion and the tibia was rotated in the internal.The surgeon considered that it was not a defect of the product and it was a technical problem.No further information was provided by the hospital.The revision surgery was performed on (b)(6) 2019 by replacing the insert as planned.However the patella was indwelled in the patient's knee joint at the revision surgery because it was not too unstable so the surgeon judged to leave the patella as it was.And the patient is under the follow-up observation.It was an implant patella.

Manufacturer Narrative

(b)(4).No device associated with this report was received for examination.Depuy considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.If information is obtained that was not available for the initial medwatch, a follow-up medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: UNKNOWN KNEE TIBIAL TRAY
• Type of Device: KNEE TIBIAL TRAY
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• Manufacturer Contact: kara ditty-bovard ; 1210 ward avenue; west chester, PA 19380-0988 ; 6103142063
• MDR Report Key: 8439556
• MDR Text Key: 139430156
• Report Number: 1818910-2019-87992
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: UNK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/01/2019

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK KNEE TIBIAL TRAY
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/01/2019
• Initial Date FDA Received: 03/21/2019
• Supplement Dates Manufacturer Received: 04/12/2019
• Supplement Dates FDA Received: 04/23/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention