MAUDE Adverse Event Report: DEPUY IRELAND - 3015516266 ATTUNE FB TIB BASE SZ 5 POR; KNEE IMPLANT - TIBIAL TRAY

Model Number 1506-21-005

Device Problem Migration (4003)

Patient Problem Insufficient Information (4580)

Event Date 05/09/2023

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on 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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

It was reported that the afxm tibia subsided 2.5 weeks after surgery.Unsure if there was a fracture on the lateral tibia.Converted to fb rev tibia with cemented stem and lateral augment.Doi: (b)(6) 2023; dor: (b)(6) 2023; affected side : right knee.There was no surgical delay.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.Device history lot: the lot number: ja05a0194 does not reflect a valid finished goods lot number.Therefore, a manufacturing records evaluation (mre) was not performed as no valid finished goods lot number was provided for this device.

• Brand Name: ATTUNE FB TIB BASE SZ 5 POR
• Type of Device: KNEE IMPLANT - TIBIAL TRAY
• Manufacturer (Section D): DEPUY IRELAND - 3015516266; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): DEPUY IRELAND 9616671; loughbeg, ringaskiddy co.; cork ; EI
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 16983813
• MDR Text Key: 315753366
• Report Number: 1818910-2023-10565
• Device Sequence Number: 1
• Product Code: MBH
• UDI-Device Identifier: 10603295507420
• UDI-Public: 10603295507420
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K213781
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/19/2023

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 Model Number: 1506-21-005
• Device Catalogue Number: 150621005
• Device Lot Number: JA05A0194
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/09/2023
• Initial Date FDA Received: 05/23/2023
• Supplement Dates Manufacturer Received: 05/29/2023
• Supplement Dates FDA Received: 05/29/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Treatment: ATUNE CR RT MS INS SZ 6 12
• Patient Outcome(s): Required Intervention
• Patient Age: 66 YR
• Patient Sex: Female