MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US HP UNI INS SZ3 7MM RMLL AOX; INSERT

Model Number 1024-56-307

Device Problem Naturally Worn (2988)

Patient Problem Pain (1994)

Event Date 01/10/2023

Event Type  Injury  

Event Description

Patient is being revised for knee pain.The doctor explanted the tibial insert and removed a small piece of cement that was in the joint area.A new sz 3rm, 7mm insert was implanted.The original dos (b)(6) 2023.Patient right knee.There was no delay in surgery.There was no injury to the patient.

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.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : the device associated with this report was not returned to depuy synthes for evaluation.The photo investigation confirm the reported allegation, damage/wear can be seen on the insert condyles.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot : a search of the depuy nonconformance (nc) quality system found no nc¿s associated with this product/lot combination.Based on the inability to find any nc¿s against the provided product code/lot code combination, it is reasonable to conclude that there are no anomalies with regard to manufacturing or inspection contained in the device history records that would contribute to the reported event.

• Brand Name: HP UNI INS SZ3 7MM RMLL AOX
• Type of Device: INSERT
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY RAYNHAM, A DIV. OF DEPUY ORTHO 1219655; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 16278054
• MDR Text Key: 308554873
• Report Number: 1818910-2023-02610
• Device Sequence Number: 1
• Product Code: HRY
• UDI-Device Identifier: 10603295501855
• UDI-Public: 10603295501855
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K193549
• 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: 02/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1024-56-307
• Device Catalogue Number: 102456307
• Device Lot Number: JP8518
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/07/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/07/2021
• 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: HP UNI INS SZ3 7MM RMLL AOX; SMARTSET MV 40G - EO
• Patient Outcome(s): Required Intervention
• Patient Age: 71 YR
• Patient Sex: Female
• Patient Weight: 87 KG