MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US ENDURANCE BONE CEMENT 40G; BONE CEMENT : BONE CEMENT

Catalog Number 3070040

Device Problem Difficult to Open or Remove Packaging Material (2922)

Patient Problem Insufficient Information (4580)

Event Date 11/01/2022

Event Type  malfunction  

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 on (b)(6) 2022, the patient underwent the tha procedure for oa.The surgeon could not take out the cement package in question from the outer package because the inside of the outer package (non-sterilized) and inner package (sterilized) had been stuck together.The surgery was completed successfully within 30 minutes delay.No further information is available.

Manufacturer Narrative

Product complaint (b)(4).Investigation summary : the device associated with this complaint was not received for examination and the received photograph does not represent the reported allegation.However the product and lot# associated with this complaint is under investigation and we have found that the cement powder inner bag is overlapping with the paper outer foil for other cements in this same lot#.Additionally we have not found any compromise in the sterility and/or the product.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 past nc¿s associated with this product/lot combination.An nc has been raised to address the current complaint condition.

• Brand Name: ENDURANCE BONE CEMENT 40G
• Type of Device: BONE CEMENT : BONE CEMENT
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY CMW - 9610921; cornford rd; blackpool FY4 4 QQ; UK FY4 4QQ
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 15835912
• MDR Text Key: 306897622
• Report Number: 1818910-2022-23368
• Device Sequence Number: 1
• Product Code: LOD
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 3070040
• Device Lot Number: 3766137
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/26/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1