MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH SIMPLEX P - US FULL DOSE 10-PK; BONE CEMENT

Catalog Number 61911010

Device Problem Insufficient Information (3190)

Patient Problem No Patient Involvement (2645)

Event Date 10/17/2018

Event Type  malfunction  

Manufacturer Narrative

An event regarding pack damage involving simplex bone cement was reported.The event was not confirmed.Method & results: product evaluation and results: not performed as no product was returned for evaluation, no photographs of the event were provided.Clinician review: no medical records were received for review with a clinical consultant.Product history review: indicated all products were manufactured and accepted into final stock with no relevant reported discrepancies.Complaint history review: there has been one other similar event for the lot referenced.Conclusion: the event itself could not be confirmed as insufficient information was provided.The event description indicates that the "hospital received cases of cement (2 cases inside 1 box) and noticed smell coming from box".Based on the information provided, it appears that this product was damaged shortly before or during delivery.The liquid monomer from the ampoule lasts a short period of time as the liquid evaporates when exposed to the atmosphere.Based on the information provided, it appears that this product was damaged due to inappropriate handling during distribution/transportation.No further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.Not returned to the manufacturer.

Event Description

As reported: "hospital received cases of cement (2 cases inside 1 box) and noticed smell coming from box.There was no damage to outside of box.They did not open to see what the damage was.Hospital disposed of [the box] and new cement was shipped".

• Brand Name: SIMPLEX P - US FULL DOSE 10-PK
• Type of Device: BONE CEMENT
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-LIMERICK; raheen business park; limerick NA
• Manufacturer Contact: joann lavatelli ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 8065838
• MDR Text Key: 128417590
• Report Number: 0002249697-2018-03710
• Device Sequence Number: 1
• Product Code: LOD
• UDI-Device Identifier: 37613327128445
• UDI-Public: 37613327128445
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K062553
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/13/2018

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 Expiration Date: 02/28/2021
• Device Catalogue Number: 61911010
• Device Lot Number: RFZ076
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/17/2018
• Initial Date FDA Received: 11/13/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/14/2018
• 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
• Patient Outcome(s): Other