MAUDE Adverse Event Report: DEPUY IRELAND - 3015516266 ATTUNE FB TIB BASE SZ 4 POR; KNEE IMPLANT - TIBIAL TRAY

Catalog Number 150621004

Device Problems Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017)

Patient Problem Bone Fracture(s) (1870)

Event Date 09/28/2023

Event Type  malfunction  

Event Description

It was reported that on (b)(6) 2023, the patient underwent a tka for oa of the knee joint.The tibial tray in question was used in the surgery.The surgery was completed successfully without any surgical delay.Postoperative x-ray showed posterior implant was floating.According to the surgeon, it was installed all around the circumference at the time of insertion.Then, the surgeon commented that the posterior part was not installed properly.The anterior tibia might have cracked.The surgeon guessed that an unexpected load might be applied when an unfamiliar fb insert was hammered and inserted.It might have caused the issue.There was no surgical delay.No further information is available.

Manufacturer Narrative

Product complaint # : (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803 (and/or part 4, as applicable).This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes, or its employees that the report constitutes an admission that the product, 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 report, a follow-up report will be filed as appropriate.

Manufacturer Narrative

Product complaint #: (b)(4).Investigation summary: no device associated with this report was received for examination.An evaluation of the manufacturing record could not be performed as the required lot number was not provided to complete the evaluation.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of the post-market surveillance.If additional information is made available, the investigation will be updated as applicable.Device history lot: a device history record (dhr) review or manufacturing records evaluation (mre) was not possible because lot code provided is not a valid finished goods lot 4036695.

• Brand Name: ATTUNE FB TIB BASE SZ 4 POR
• Type of Device: KNEE IMPLANT - TIBIAL TRAY
• Manufacturer (Section D): DEPUY IRELAND - 3015516266; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): CORK MFG & MATERIAL WAREHOUSE; loughbeg ringaskiddy; cork
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 17916294
• MDR Text Key: 325463306
• Report Number: 1818910-2023-20708
• Device Sequence Number: 1
• Product Code: MBH
• UDI-Device Identifier: 10603295507413
• UDI-Public: 10603295507413
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K213781
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 150621004
• Device Lot Number: 4036695
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/12/2023
• 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: Unknown
• Patient Sequence Number: 1
• Treatment: UNK ATTUNE KNEE TIBIAL INSERT.