MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN INSERT; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Model Number	6485-3-111
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	02/24/2022
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.The following devices were also listed in this report: gmrs extension piece 80mm; cat# 64956080; lot# aar2c.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.
Event or Problem Description
On (b)(6) 2022, it was reported by stryker sales rep that the surgeon informed the extraction of implants by (b)(6) 2022 due to infection.Revision was in year 2017.
Additional Manufacturer Narrative
Corrected date: patient age, date of implant, device information updated to unknown.An event regarding infection involving an unknown insert was reported.The event was not confirmed.Method & results: -product evaluation and results: the reported device was not returned however a photograph was provided for review.Visual inspection of the provided photograph indicated that the devices were recently explanted as blood is visible.Nothing further can be observed from the photo.-clinician review: insufficient information was provided to support a medical review.-product history review: could not be performed as the device lot details were not provided.-complaint history review: could not be performed as the device lot details were not provided.Conclusions: all stryker products sold as sterile are validated to a minimum sterility assurance level sal of 10^-6 in accordance with applicable iso standards.The exact cause of the event could not be determined because insufficient information was provided.Further information such as pathology reports and the primary and revision operative reports 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.The following devices were also listed in this report: mrs fem stem w/o body 11x127mm; cat# 64853111; lot# 171734a gmrs extension piece 80mm; cat# 64956080; aar2c unknown gmrs femoral component; cat# unknown; lot# unknown gmrs proximal tibial implant; cat# unknown; lot# unknown stem; cat# unknown; lot# unknown bushings; cat# unknown; lot# unknown axle; cat# unknown; lot# unknown bumper; cat# unknown; lot# unknown tibial rotating component; cat# unknown; lot# unknown tibial sleeve; cat# unknown; lot# unknown it cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.
Event or Problem Description
On (b)(6) 2022, it was reported by stryker sales rep that the surgeon informed the extraction of implants by (b)(6) 2022 due to infection.Revision was in year 2017.

• Brand Name: UNKNOWN INSERT
• Common Device Name: PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
• 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: brad curtis ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 13843807
• Report Number: 0002249697-2022-00417
• Device Sequence Number: 11763100
• Product Code: MBH
• UDI-Device Identifier: 07613327048360
• UDI-Public: 07613327048360
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• PMA/510(K) Number: K040749
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/05/2022
• 2 Devices were Involved in the Event: 1 2

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: 05/31/2022
• Device Model Number: 6485-3-111
• Device Catalogue Number: UNK_JR
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/24/2022
• Supplement Date Received by Manufacturer: 09/12/2022
• Initial Report FDA Received Date: 03/21/2022
• Supplement Report FDA Received Date: 10/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2017
• 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: 45 YR
• Patient Sex: Female