MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH SIMPLEX P FULL DOSE 1 PACK; BONE CEMENT

Model Number 6191-1-001

Device Problem Insufficient Information (3190)

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

Event Date 08/04/2020

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.

Event Description

This pi is for the (b)(6) 2020 event.Cement hardened before it could be applied effectively.(b)(6) 2020 making antibiotic beads they had issues (this pi) and (b)(6) 2020 cementing a competitor stem during a hemiarthroplasty case.Surgical delay: yes.Update: "surgical delay of ten minutes to get a new mixer and redo cement for the beads.".

Event Description

This pi is for the (b)(6) 2020 event.Cement hardened before it could be applied effectively.(b)(6) 2020 making antibiotic beads they had issues (this pi) and (b)(6) 2020 cementing a competitor stem during a hemiarthroplasty case.Surgical delay: yes.Update: "surgical delay of ten minutes to get a new mixer and redo cement for the beads.".

Manufacturer Narrative

Corrected data expiration and manufacturing dates.Additional manufacturer narrative.Reported event: an event regarding setting time involving a simplex cement mix was reported.The event was not confirmed.Method & results: device evaluation and results: visual inspection was performed on three of the retain samples and the returned sample 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.Functional testing was performed on three of the retain samples and returned sample of the reported lot to verify the doughing time, working time and setting time of the product.The laboratory report shows that the samples met the required specification for the test.Clinician review: 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 1 other similar events for the lot referenced.This represents the other simplex cement pack used within the same event, therefore no further trending is required for this commonality.Conclusion: it was reported that the cement hardened before it could be applied effectively.The event was not confirmed.Visual inspection was performed on three of the retain samples and returned sample 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.Functional testing was performed on three of the retain samples and returned sample of the reported lot to verify the doughing time, working time and setting time of the product.The laboratory report shows that the samples met the required specification for the test.The exact cause of the event could not be determined because insufficient information was provided.Additional information including details of mixing technique, storage and using environment and return of the product are needed to fully investigate the event.If further information becomes available or the product is returned, this investigation will be re-opened.

• Brand Name: SIMPLEX P FULL DOSE 1 PACK
• Type of Device: BONE CEMENT
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 10479948
• MDR Text Key: 205291260
• Report Number: 0002249697-2020-01779
• Device Sequence Number: 1
• Product Code: LOD
• UDI-Device Identifier: 07613327128444
• UDI-Public: 07613327128444
• Combination Product (y/n): N
• PMA/PMN Number: K062553
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 12/04/2020

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: 08/31/2021
• Device Model Number: 6191-1-001
• Device Catalogue Number: 6191-1-001
• Device Lot Number: RBB021
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/16/2020
• Initial Date Manufacturer Received: 08/06/2020
• Initial Date FDA Received: 09/01/2020
• Supplement Dates Manufacturer Received: 11/11/2020
• Supplement Dates FDA Received: 12/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 63 YR