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

Catalog Number 61910002

Device Problems Device Difficult to Setup or Prepare (1487); Insufficient Information (3190)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/30/2020

Event Type  malfunction  

Manufacturer Narrative

Review of the device history records indicate that devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.The event involves a device that is not cleared for sale in the u.S., but similar device is commercially available in the u.S.Device not returned.

Event Description

After the bone cement was stirred, it hardened early.It may have been taken out of the refrigerator earlier.Are there similar events in the same lot?.

Manufacturer Narrative

Corrected the type of reportable event.Reported event: an event regarding setting time of bone cement involving simplex p-japanese twin pack was reported.The event was not confirmed.Method & results: device evaluation and results: visual inspection: visual inspection was performed on three of the retain samples of the reported lot while mixing the cement product.No unusual characteristics were observed during the mixing.It was also stated that the cement was seen to have a homogeneous appearance.Refer to attached laboratory results in communications tab.Dimensional inspection: not performed and not relevant to this event which relates to the setting time of bone cement.Functional inspection: 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 attached laboratory report show that the samples met the required specification for the test.Material analysis: not performed and not relevant to this event which relates to the setting time of bone cement.Medical records received and evaluation: no medical records were received for review with a clinical consultant.  device history review: all devices were manufactured and accepted into final stock with no relevant reported discrepancies.Complaint history review: there have been no other similar events for the reported lot.Conclusions: it was reported during surgery after the bone cement was stirred, it hardened early.It may have been taken out of the refrigerator earlier.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 attached laboratory report show that the samples met the required specification for the test.Visual inspection was performed of the reported lot while mixing the cement product.No unusual characteristics were observed during the mixing.It was also stated that the cement was seen to have a homogeneous appearance.The results met the specification for the test.No further investigation for this event is possible at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.H3 other text : device not returned.

Event Description

After the bone cement was stirred, it hardened early.It may have been taken out of the refrigerator earlier.Are there similar events in the same lot?.

• Brand Name: SIMPLEX P-JAPANESE TWIN PACK
• Type of Device: BONE CEMENT
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 10282530
• MDR Text Key: 199069681
• Report Number: 0002249697-2020-01463
• 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: health professional
• Type of Report: Initial,Followup
• Report Date: 12/09/2020

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: 12/31/2023
• Device Catalogue Number: 61910002
• Device Lot Number: JJA040
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/30/2020
• Initial Date FDA Received: 07/16/2020
• Supplement Dates Manufacturer Received: 11/17/2020
• Supplement Dates FDA Received: 12/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other