MAUDE Adverse Event Report: DEPUY CMW - 9610921 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 09/14/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(4).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 tka procedure for knee 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 without any surgical delay.

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 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.,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.

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 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 CMW - 9610921; cornford rd; cornford rd; blackpool FY4 4 QQ; UK FY4 4QQ
• 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: 15501504
• MDR Text Key: 301549528
• Report Number: 1818910-2022-18971
• 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,Followup
• Report Date: 09/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2022
• 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: 12/06/2022
• 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: Initial
• Patient Sequence Number: 1