MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 ENDURANCE BONE CEMENT 40G; BONE CEMENT : BONE CEMENT

Catalog Number 3070040

Device Problems Packaging Problem (3007); Insufficient Information (3190)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/05/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Investigation summary
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> the complaint states ¿it was reported that the odour occurred from the product stocked at hospital on (b)(6) 2018.There was no adverse consequence to the patient.No further information was provided by hospital.¿ as the product sample was not returned for analysis, this investigation is based on the information contained in this complaint report and is limited.Without a sample or photographs, it is not possible to establish further information for the investigation.It can be inferred from the odour described in the complaint that the ampoule containing monomer has broken.Without further information, it is not possible to determine when this damage originated or how serious the damage is.Fmea dva-107020-fde rev 6 lines 115 and 116 refer to this failure mode (b)(4).In conclusion, this is a known failure mode and the current rate of complaints for this issue is within the expected occurrence rate, no information received with this individual complaint indicated that a broader investigation or corrective action was necessary.Depuy synthes considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.Device history lot
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> device history reviewed: 2 unrelated non-conformances on this batch.Final micro and sterility tests passed.Complaints database searched: a complaint database search on the provided lot number found 2 additional reports, 1 related to a broken ampoule, and 1 unrelated.Total for lot number: 2 ((b)(4)).Additional narrative: if information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

An odor occurred from the product stocked at hospital on (b)(6) 2018.There was no adverse consequence to the patient.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provision of 21 cfr, part 803.The report may be based on the 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.H10 additional narrative: product complaint # (b)(4).Investigation summary: the complaint states ¿it was reported that the odour occurred from the product stocked at hospital on (b)(6) 2018.There was no adverse consequence to the patient.No further information was provided by hospital.¿ as the product sample was not returned for analysis, this investigation is based on the information contained in this complaint report and is limited.Without a sample or photographs, it is not possible to establish further information for the investigation.It can be inferred from the odour described in the complaint that the ampoule containing monomer has broken.Without further information, it is not possible to determine when this damage originated or how serious the damage is.Fmea dva-107020-fde rev 6 lines 115 and 116 refer to this failure mode.In conclusion, this is a known failure mode and the current rate of complaints for this issue is within the expected occurrence rate, no information received with this individual complaint indicated that a broader investigation or corrective action was necessary.Depuy synthes considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.Device history lot: device history reviewed: 2 unrelated non-conformances on this batch.Final micro and sterility tests passed.Complaints database searched: a complaint database search on the provided lot number found 2 additional reports, 1 related to a broken ampoule, and 1 unrelated.Total for lot number: 2 (b)(4).Device history batch: null.Device history review: null.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: ENDURANCE BONE CEMENT 40G
• Type of Device: BONE CEMENT : BONE CEMENT
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 7929623
• MDR Text Key: 122639942
• Report Number: 1818910-2018-71124
• Device Sequence Number: 1
• Product Code: LOD
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 09/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 8159688
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/11/2018
• Initial Date FDA Received: 10/03/2018
• Supplement Dates Manufacturer Received: 08/13/2019
• Supplement Dates FDA Received: 08/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1