MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH SIMPLEX P-JAPANESE TWIN PACK; BONE CEMENT, ANTIBIOTIC

Catalog Number 61910002

Device Problems Improper Chemical Reaction (2952); Insufficient Information (3190)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/05/2020

Event Type  malfunction  

Manufacturer Narrative

The reported device is specific to (b)(6) but it is similar to a stryker device that is commercially available in the us it was noted that the device is not available for evaluation.Should additional information become available, the evaluation summary will be submitted in a supplemental report.

Event Description

The indication was for bha (left) due to fracture of the base of the femoral neck (patient's native bone).Cement is usually added after 4 minutes, but this time it was quite hard at about 3 minutes, making it difficult to inject cement.The second set started to be inserted in 4 minutes and was still soft after 5 minutes.

Event Description

The indication was for bha (left) due to fracture of the base of the femoral neck (patient's native bone).Cement is usually added after 4 minutes, but this time it was quite hard at about 3 minutes, making it difficult to inject cement.The second set started to be inserted in 4 minutes and was still soft after 5 minutes.

Manufacturer Narrative

An event regarding setting time involving a simplex cement mix was reported.The event was not confirmed.Method & results: product evaluation and results: it was also stated that the samples was seen to have a homogeneous appearance.Visual inspection was performed while mixing the cement product.No unusual characteristics were observed during the mixing.Functional testing was performed on three of the retain samples of the reported lot to verify the doughing time, working time and setting time of the product.The samples met the required specification for the test.Medical records received and evaluation: no medical records were received for review with a clinical consultant.Product history review: a review of the device manufacturing records indicate that all devices accepted into final stock were free from discrepancies.Complaint history review: there have been other similar events for the lot referenced.Conclusions: functional testing was performed on three of the retain samples of the reported lot to verify the doughing time, working time and setting time of the product.The samples met the required specification for the test.Thus, the reported event is not confirmed.The exact cause of the event could not be determined because insufficient information was provided.Further information such as the exact setting time recorded and how the setting time recorded are needed to complete the investigation for determining root cause.No further investigation for this event is possible at this time.If devices and / or additional information become available to indicate further evaluation is warranted, this record will be reopened.

• Brand Name: SIMPLEX P-JAPANESE TWIN PACK
• Type of Device: BONE CEMENT, ANTIBIOTIC
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 10910584
• MDR Text Key: 220207581
• Report Number: 0002249697-2020-02546
• Device Sequence Number: 1
• Product Code: MBB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 01/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/26/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2023
• Device Catalogue Number: 61910002
• Device Lot Number: JHA035
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other