MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH SIMPLEX HV US 1 PACK; BONE CEMENT

Catalog Number	6194-1-001
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	03/25/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Doctor revised a left medial uni originally done on (b)(6) 2023 due to persistent pain.No allegations were made against the implants.She revised to a primary triathlon with universal baseplate.
Additional Manufacturer Narrative
Stryker orthopaedics is a distributor of this device, which is manufactured by osartis.The manufacturer has responsibility for regulatory decisions and mdr/mir reporting.Supplier has been notified.Serious injury reports for hv products are also filed by stryker personnel.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.H3 other text: device not returned.
Additional Manufacturer Narrative
Reported event: an event regarding pain involving a simplex cement mix was reported.The event was not confirmed.Method & results: product evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device was not returned.Clinician review: no medical records were received for review with a clinical consultant.Product history review: check of batch documentation and performance of retain test.No deviations were detected.Complaint history review: there have been no other similar events for the lot referenced.Conclusions: it was reported that the patient was revised due to pain.The exact cause of the event could not be determined because insufficient information was provided.Further information such as return of the device, pathology reports, pre- and post-operative x-rays and the primary operative report as well as patient history and follow-up notes are needed to complete the investigation for determining root cause.Additionally, the reported device is an oem product.Written acknowledgement from the oem supplier, rm2024/033, that an investigation has been initiated at the oem supplier site was received that indicated "in order to exclude a product-specific cause, the batch documentation was checked and a retain test was carried out.No deviations were detected.A user- or patient-specific cause is possible.A report has been submitted to the fda.No further measures are possible, this complaint will be closed." if devices and/or additional information become available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
Doctor revised a left medial uni originally done on (b)(6) 2023 due to persistent pain.No allegations were made against the implants.She revised to a primary triathlon with universal baseplate.

• Brand Name: SIMPLEX HV US 1 PACK
• 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: juana hiciano ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 19130567
• Report Number: 0002249697-2024-00617
• Device Sequence Number: 6900516
• Product Code: LOD
• UDI-Device Identifier: 04260056885747
• UDI-Public: 04260056885747
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: K123225
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/31/2024

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 Catalogue Number: 6194-1-001
• Device Lot Number: 219AB824AD
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/25/2024
• Supplement Date Received by Manufacturer: 05/08/2024
• Initial Report FDA Received Date: 04/18/2024
• Supplement Report FDA Received Date: 06/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Required Intervention; Hospitalization
• Patient Age: 49 YR
• Patient Sex: Male