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 No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/06/2022

Event Type  malfunction  

Event Description

It was reported that on (b)(6) 2022, the patient underwent the tha procedure for hip oa.The surgeon could not take out the cement in question from the package because the inside of the outer package (non-sterilized) and inner package (sterilized) had been stuck together.The surgery was completed successfully without any surgical delay.No further information is available.

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).This report is being submitted pursuant to the provisions of 21 cfr, part 803.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 joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, 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.Corrected d4: (removed expiration date 3/31/2025).

Manufacturer Narrative

Product complaint (b)(4).Investigation summary: the device associated with this complaint was received for examination.Visual examination found, the cement powder inner bag overlapping with the paper outer foil.Confirming, the reported allegation.It is only slightly harder to take the cement bag from the overlapping of the paper foil, but does not compromise the integrity and/or sterility of the final product.Additional complaint information, monitoring for potential safety signals will be conducted through complaint trending as part of post-market surveillance.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: 15446621
• MDR Text Key: 300579093
• Report Number: 1818910-2022-18207
• 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,Followup
• Report Date: 09/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/19/2022
• 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?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/23/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/11/2022
• 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