MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH SIMPLEX P - US FULL DOSE 10-PK; BONE CEMENT

Catalog Number	61911010
Medical Device Problem Codes	Unstable (1667); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Ambulation or Postural Difficulties (2544); Joint Laxity (4526)
Date of Event	06/28/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other similar events for the lot referenced.It was noted that the device is not available for evaluation.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.The information in this report was provided by stryker orthopaedics legal affairs department.No additional information is available at this time due to the ongoing litigation.Should additional information become available, the evaluation summary will be submitted in a supplemental report.Device not available.
Event or Problem Description
It was reported through the communication of an attorney that allegedly the patient was revised due to painful and unstable left total knee arthroplasty.
Additional Manufacturer Narrative
Reported event: an event regarding instability involving a simplex cement mix was reported.Conclusion: it was reported that the patient's knee was revised due to painful and unstable left total knee arthroplasty whereby the triathlon x3 cs 16 mm insert was revised with a triathlon x3 cs 19mm insert.The patella, femoral component and baseplate were well fixed and remained implanted.Based on the information provided there is no indication or allegation that the device reported in this investigation contributed to the event and is therefore considered concomitant.No further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
It was reported through the communication of an attorney that allegedly the patient was revised due to painful and unstable left total knee arthroplasty.*update on 11-march-2022 per medical review: "[.] june 28, 2017: there is in operation report from dr.The pre-and postop diagnosis was painful and unstable left total knee arthroplasty.The operation performed was a revision left total knee arthroplasty.The implants utilized were a stryker triathlon x3 19 mm polyethylene insert cs size #6.Operative findings included well fixed implants, no patella wear, mild posterior medial tibial insert wear, a flexion gap that was equal in size to the extension gap, competent posterior cruciate ligament, femoral axial rotation slightly external to the tibia with the tibial rotation at the junction of the medial and middle third of the tibial tubercle.There was clear yellow fluid present but no evidence of infection.A 19 mm cs insert provided satisfactory stability according to the surgeon.[.]".

• Brand Name: SIMPLEX P - US FULL DOSE 10-PK
• Common Device Name: BONE CEMENT
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-LIMERICK; raheen business park; limerick NA ; EI NA
• Manufacturer Contact: anna ryan ; raheen business park; limerick NA ; EI NA ; 61498200
• MDR Report Key: 10842935
• Report Number: 0002249697-2020-02468
• Device Sequence Number: 3644244
• Product Code: LOD
• UDI-Device Identifier: 37613327128445
• UDI-Public: 37613327128445
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K062553
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/06/2022

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: 08/31/2015
• Device Catalogue Number: 61911010
• Device Lot Number: RKT186
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/22/2020
• Supplement Date Received by Manufacturer: 03/15/2022
• Initial Report FDA Received Date: 11/16/2020
• Supplement Report FDA Received Date: 04/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/22/2012
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 58 YR
• Patient Sex: Male