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 08/05/2020

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 has been another event for the lot referenced.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.Device not returned.

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 ((b)(4)) and (b)(6) 2020 cementing a competitor stem during a hemiarthroplasty case (this pi).Surgical delay: yes.Update per email received: procedure: cemented hemiarthroplasty.Surgical delay: 30 minutes to remove hardened cement in the femoral canal during hemiarthroplasty.

Manufacturer Narrative

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 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 of the reported lot to verify the doughing time, working time and setting time of the product.The laboratory report indicates 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 no other similar events for the reported lot.Conclusion: it was reported that cement hardened before it could be applied effectively.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.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 laboratory report indicates that the samples met the required specification for the test.The event was not confirmed.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.

Event Description

This pi is for the (b)(6)2020 event.Cement hardened before it could be applied effectively.8/4/2020 making antibiotic beads they had issues (b)(4) and (b)(6) 2020 cementing a competitor stem during a hemiarthroplasty case (b)(4).Surgical delay: yes.Update per email received: procedure: cemented hemiarthroplasty.Surgical delay: 30 minutes to remove hardened cement in the femoral canal during hemiarthroplasty.

• 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: 10480281
• MDR Text Key: 219180356
• Report Number: 0002249697-2020-01782
• 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: 12/01/2020

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 Model Number: 6191-1-001
• Device Catalogue Number: 6191-1-001
• Device Lot Number: RBB021
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/06/2020
• Initial Date FDA Received: 09/01/2020
• Supplement Dates Manufacturer Received: 11/06/2020
• Supplement Dates FDA Received: 12/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 40 YR
• Patient Weight: 157