MAUDE Adverse Event Report: DEPUY IRELAND 9616671 ATUNE CRS FB TIB BASE SZ 4 CEM; ATTUNE STEMMABLE TIBIA IMPLANTS : KNEE TIBIAL TRAY

Catalog Number 150640004

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Bone Fracture(s) (1870); No Code Available (3191)

Event Date 11/16/2018

Event Type  Injury  

Manufacturer Narrative

Product complaint : (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.(b)(4).

Event Description

Clinical adverse event received for intraoperative tibial plateau fracture.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: 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: ATUNE CRS FB TIB BASE SZ 4 CEM
• Type of Device: ATTUNE STEMMABLE TIBIA IMPLANTS : KNEE TIBIAL TRAY
• Manufacturer (Section D): DEPUY IRELAND 9616671; loughbeg, ringaskiddy co.; cork ; EI
• Manufacturer (Section G): DEPUY IRELAND 9616671; loughbeg, ringaskiddy co.; cork ; EI
• Manufacturer Contact: kara ditty-bovard ; 1210 ward avenue; west chester, PA 19380 ; 6103142063
• MDR Report Key: 8247591
• MDR Text Key: 133044065
• Report Number: 1818910-2019-80889
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 10603295042785
• UDI-Public: 10603295042785
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K160700
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,study
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/18/2018

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: 150640004
• Device Lot Number: 8688504
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/18/2018
• Initial Date FDA Received: 01/15/2019
• Supplement Dates Manufacturer Received: 01/24/2019
• Supplement Dates FDA Received: 01/25/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/10/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Weight: 78