MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH SIMPLEX P WITH TOBRAMYCIN 1 PACK; BONE CEMENT, ANTIBIOTIC

Catalog Number	6197-9-001
Medical Device Problem Code	Loss of Osseointegration (2408)
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	12/03/2024
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.Review of the device history records indicate devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.
Event or Problem Description
It was reported that the patient's left knee was revised due to loosening of the tibia and femur.Intra-operatively, it was also observe that both stems (tibial and femoral) broke off approximately halfway up their threading.The patient's ts knee was converted to a competitor revision knee (patellar component was retained).Rep confirmed that no further information will be released by the hospital or surgeon.
Additional Manufacturer Narrative
Reported event: an event regarding loosening involving a simplex cement mix was reported.The event was not confirmed.Method and results: product evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device was not returned.Clinician review: a review of the provided medical records by a clinical consultant stated the following comment: a revision tka with pressfit stems was revised.Intraoperatively both the femoral and tibial stems were found to be fractured.The root cause of this mechanical complication cannot be determined from the documentation provided.Product history review: there have been 1 other similar events for the lot referenced relates to loosening for the same device/patient therefore no further trending is required.Complaint history review: there have been no other similar events for the lot referenced.Conclusions: a review of the provided medical records by a clinical consultant stated the following comment: a revision tka with pressfit stems was revised.Intraoperatively both the femoral and tibial stems were found to be fractured.The root cause of this mechanical complication cannot be determined from the documentation provided.The exact cause of the event could not be determined because insufficient information was provided.Further information such as return of the device as well as patient history and follow-up notes are needed to complete the investigation for determining root cause.No further investigation for this event is possible at this time.If devices and/or additional information become available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
It was reported that the patient's left knee was revised due to loosening of the tibia and femur.Intra-operatively, it was also observe that both stems (tibial and femoral) broke off approximately halfway up their threading.The patient's ts knee was converted to a competitor revision knee (patellar component was retained).Rep confirmed that no further information will be released by the hospital or surgeon.

• Brand Name: SIMPLEX P WITH TOBRAMYCIN 1 PACK
• Common Device Name: BONE CEMENT, ANTIBIOTIC
• 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, NJ NA ; EI NA ; 2018315000
• MDR Report Key: 20937363
• Report Number: 0002249697-2024-01728
• Device Sequence Number: 19975234
• Product Code: MBB
• UDI-Device Identifier: 07613327128420
• UDI-Public: 07613327128420
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: K014199
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/03/2025

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: 06/30/2019
• Device Catalogue Number: 6197-9-001
• Device Lot Number: MDV028
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/03/2024
• Supplement Date Received by Manufacturer: 03/28/2025
• Initial Report FDA Received Date: 12/16/2024
• Supplement Report FDA Received Date: 04/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/04/2014
• 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: 73 YR
• Patient Sex: Male
• Patient Weight: 95 KG