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

Catalog Number UNK_JR

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Unspecified Infection (1930); Pain (1994); Swelling/ Edema (4577)

Event Date 12/08/2022

Event Type  Injury  

Event Description

Racer related event (anonymised trial) - no other information available: "right total knee replacement (b)(6) 2022.Seen gp (b)(6) 2022 with pain and swelling checked for dvt, given flucloxacillin for 3 days then clarithromycin.Presented to a&e on(b)(6) 2022.Admitted had right knee aspiration on (b)(6) 2022 - straw coloured fluid 15mls aspirated - culture negative crp 141 (referred back seen on (b)(6) 2022).Discharged (b)(6) 2022.Admitted on (b)(6) 2022.Had dair procedure seen by bone infection team.Is now on antibiotics until (b)(6) 2023.Discharged from hospital on (b)(6) 2023.Patient was prescribed 12 weeks antibiotics late (b)(6) 2022.He was discharged from hospital (b)(6) 2023.His antibiotics, doxycycline and ciprofolxacin, were stopped on (b)(6) 2023.He was discharged from the bone infection team on the same day.He has been seen by the surgeons twice since (last seen (b)(6) 2023) and there are no further signs of infection."".

Manufacturer Narrative

An evaluation of the device cannot be performed as the device was not returned to the manufacturer. should additional information become available it will be reported in a supplemental report upon completion of the investigation.

Event Description

Racer related event (anonymised trial) - no other information available: "right total knee replacement (b)(6) 2022.Seen gp (b)(6) 2022 with pain and swelling checked for dvt, given flucloxacillin for 3 days then clarithromycin.Presented to a&e on (b)(6) 2022.Admitted had right knee aspiration on (b)(6) 2022 - straw coloured fluid 15mls aspirated - culture negative crp 141 (referred back seen on (b)(6) 2022).Discharged (b)(6) 2022.Admitted on (b)(6) 2022.Had dair procedure seen by bone infection team.Is now on antibiotics until march 2023.Discharged from hospital on (b)(6) 2023.Patient was prescribed 12 weeks antibiotics late december 2022.He was discharged from hospital (b)(6) 2023.His antibiotics, doxycycline and ciprofolxacin, were stopped on (b)(6) 2023.He was discharged from the bone infection team on the same day.He has been seen by the surgeons twice since (last seen (b)(6) 2023) and there are no further signs of infection."".

Manufacturer Narrative

Reported event: an event regarding infection involving an unknown knee 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 remains implanted.-clinician review: no medical records were received for review with a clinical consultant.-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: it was reported that the patient was revised due to infection.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 return of the device, pathology reports, pre- and post-operative x-rays and the revision operative report 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.

• Brand Name: UNKNOWN_KNEE
• Type of Device: 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-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer Contact: sanjana talathi ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 18311502
• MDR Text Key: 330289399
• Report Number: 0002249697-2023-01547
• Device Sequence Number: 1
• Product Code: MBH
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/20/2024

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
• Device Operator: Health Professional
• Device Catalogue Number: UNK_JR
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/24/2023
• Initial Date FDA Received: 12/12/2023
• Supplement Dates Manufacturer Received: 02/22/2024
• Supplement Dates FDA Received: 03/20/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization