MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH SPEEDSET-US FULL DOSE 10 PK; BONE CEMENT, ANTIBIOTIC

Catalog Number	61921010
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	10/17/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Pt called to report that their husband had a left partial hip replacement that was done on (b)(6) of 2019 and it was failing.They wanted to know if there had been a recall.The prothesis was a competitor the only stryker product was the cement.Recall enquiry.
Additional Manufacturer Narrative
The following devices were also listed in this report: md universal cement restrictor; cat # b000-0240; lot # 6m9487.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.Reported event an event regarding other (pending revision) involving a simplex cement mix was reported.The event was not confirmed.Method & results -product evaluation and results: not performed as the device remains implanted.-clinician review: no medical records were received for review with a clinical consultant.-product history review: review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.-complaint history review: there have been 1 other similar events for the lot referenced for the same patient; therefore, no lot commonality is required.Conclusion: it was reported that the patient is impeding revision.The exact cause of the event could not be determined because insufficient information was provided.Further information such as 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 patient would like to know if the device is in scope of a recall.Based of the the catalog and lot number; this device is not in scope of a recall.No further investigation for this event is possible at this time.If additional information become available to indicate further evaluation is warranted, this record will be reopened.

• Brand Name: SPEEDSET-US FULL DOSE 10 PK
• 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: marisol santiago ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 20662617
• Report Number: 0002249697-2024-01534
• Device Sequence Number: 18194736
• Product Code: MBB
• UDI-Device Identifier: 37613327128452
• UDI-Public: 37613327128452
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/12/2024

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 Expiration Date: 10/31/2020
• Device Catalogue Number: 61921010
• Device Lot Number: DAA002
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/17/2024
• Initial Report FDA Received Date: 11/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/11/2019
• 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: Other
• Patient Age: 88 YR
• Patient Sex: Male
• Patient Weight: 79 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White