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

Catalog Number 61911010

Device Problems Break (1069); Fracture (1260); Leak/Splash (1354)

Patient Problem No Patient Involvement (2645)

Event Date 11/13/2018

Event Type  malfunction  

Manufacturer Narrative

Reported event: 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 product was not returned for evaluation.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 have been no other similar events for the lot referenced.Conclusion: the event itself could not be confirmed as insufficient information was provided.The event description indicates that the "there was visible liquid damage inside and outside of the shipping container, on the outer box of the 10-pack, and on the bottom box in the 10-pack container.There was an odour".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.Device not returned.

Event Description

As reported: "box of cement was opened and leaked out in shipment".Additional no pictures are available.The 10-pack was open in the shipping container, and the bottom box in the 10-pack was open.The shipping container "looked ok".No packing material was used in the shipping container.Only one 10-dose box was in the shipping container.There was visible liquid damage inside and outside of the shipping container, on the outer box of the 10-pack, and on the bottom box in the 10-pack container.There was an odour.The 10-pack was disposed by the hospital.

• Brand Name: SIMPLEX P - US FULL DOSE 10-PK
• Type of Device: POLYMETHYLMETHACRYLATE (PMMA) 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: joanne mahony ; ida industrial estate; carrigtwohill NA ; 214532800
• MDR Report Key: 8152435
• MDR Text Key: 130335567
• Report Number: 0002249697-2018-03974
• 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: 12/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2021
• Device Catalogue Number: 61911010
• Device Lot Number: RJZ103
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/13/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/11/2018
• 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