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

Model Number	6191-1-001
Medical Device Problem Code	Device Difficult to Setup or Prepare (1487)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	08/26/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was noted that the device is not available for evaluation.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.Device not returned.
Event or Problem Description
Simplex p set hard in 4-5 minutes.Update: the nature of the procedure being performed was a total hip.The patient's femur fractured, requiring cables.Surgical delay of unknown duration.
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 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.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 two other similar events for the lot referenced.All relate to the same event for the same patient and are within this pi therefore, no further trending is required for this commonality.Conclusion: it was reported that the hospital felt the simplex product setting time was quicker than anticipated setting time.The event was not confirmed.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 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.H3 other text : device not returned.
Event or Problem Description
Simplex p set hard in 4-5 minutes.Update: the nature of the procedure being performed was a total hip.The patient's femur fractured, requiring cables.Surgical delay of unknown duration.

• Brand Name: SIMPLEX P FULL DOSE 1 PACK
• Common Device Name: BONE CEMENT
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 10567214
• Report Number: 0002249697-2020-01968
• Device Sequence Number: 11417648
• Product Code: LOD
• UDI-Device Identifier: 07613327128444
• UDI-Public: 07613327128444
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K062553
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2022
• Device Model Number: 6191-1-001
• Device Catalogue Number: 6191-1-001
• Device Lot Number: RCB035
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/27/2020
• Supplement Date Received by Manufacturer: 12/23/2020
• Initial Report FDA Received Date: 09/22/2020
• Supplement Report FDA Received Date: 01/18/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention