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 Problem Pain (1994)

Event Date 10/01/2018

Event Type  Injury  

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.

Event Description

Patient stated he had a left tka done on (b)(6) 2018, he was implanted with stryker cement and competitor implants.Patient had physical therapy after surgery.On (b)(6) 2018 patient started to experience excruciating pain walking up and down the stairs.On (b)(6) 2019 he saw dr.(b)(6) and was recommend a bone scan, based on the results he was told he needed to be revised as the cement used was debonded and breaking up.Patient reached out to his primary surgeon and was revised.Patient had physical therapy.In mid (b)(6) 2019 patient started to experience excruciating pain.He went for an x-ray and a couple of days later he had an mri and was told he had a fractured knee cap due to the cement breaking up and debonding.Two months ago patient stated he was walking down the stairs when felt a pop, could not lift his left heel up and experienced excruciating pain.He had an emergency mri and met with his surgeon and was told he had scar tissue that had developed.Patient is still experiencing excruciating pain.Patient is seeking compensation.This pi is for revision of the primary.

Manufacturer Narrative

Reported event: an event regarding loosening and periprosthetic fracture involving a simplex cement mix was reported.Method & results: device evaluation and results: not performed as the associated device is oem product.Clinician review: not performed as the associated device is oem product.Device history review: not performed as the associated device is oem product.Complaint history review: not performed as the associated device is oem product.Conclusions: the reported device is an oem product.Written acknowledgement from the oem supplier that an investigation has been initiated at the oem supplier site was received, and has been attached within the communication log.See supplier issue ref #rm2020/116.Corrective action/preventive action: no action is required by stryker at this time as the investigation for this event is performed by the oem.

Event Description

Patient stated he had a left tka done on (b)(6) 2018, he was implanted with stryker cement and competitor implants.Patient had physical therapy after surgery.On (b)(6) of 2018 patient started to experience excruciating pain walking up and down the stairs.On (b)(6) 2019 he saw dr.(b)(6) and was recommend a bone scan, based on the results he was told he needed to be revised as the cement used was debonded and breaking up.Patient reached out to his primary surgeon and was revised.Patient had physical therapy.In mid (b)(6) 2019 patient started to experience excruciating pain.He went for an x-ray and a couple of days later he had an mri and was told he had a fractured knee cap due to the cement breaking up and debonding.Two months ago patient stated he was walking down the stairs when felt a pop, could not lift his left heel up and experienced excruciating pain.He had an emergency mri and met with his surgeon and was told he had scar tissue that had developed.Patient is still experiencing excruciating pain.Patient is seeking compensation.This pi is for revision of the primary.

• 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: 10654514
• MDR Text Key: 210598720
• Report Number: 0002249697-2020-02086
• 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: consumer
• Type of Report: Initial,Followup
• Report Date: 12/10/2020

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
• Device Operator: Health Professional
• Device Model Number: 6191-1-001
• Device Catalogue Number: 6191-1-001
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/15/2020
• Initial Date FDA Received: 10/09/2020
• Supplement Dates Manufacturer Received: 11/20/2020
• Supplement Dates FDA Received: 12/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 64 YR
• Patient Weight: 98