MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH MRS FEM STEM W/0 BODY 15X127MM; PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER

Model Number 6485-3-115

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

Patient Problems Muscular Rigidity (1968); Pain (1994); Loss of Range of Motion (2032); Fungal Infection (2419); Unequal Limb Length (4534)

Event Date 12/03/2019

Event Type  Injury  

Event Description

Patient reported he had a left knee tka done on 1999 and was revised on 2017 due to pain and on 2019 (stryker implants) due to fungal infection.Patient is unsure if the 1999 and 2017 implants are stryker.Patient stated his pain never went away and over the last year the pain has become extreme.His rom has decreased to 45 degrees and has leg discrepancy, his left leg is shorted than his right leg.Patient is attending pain management.Patient would like to know if his implants are part of a recall.The patient would like assistance with his revision as this is his fourth revision and there's a risk of amputation.The patient would also like assistance with who will be the best surgeon to go to as he does not want to get amputated.

Manufacturer Narrative

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.

Manufacturer Narrative

The following devices were also listed in this report: gmrs dist fem comp std l 65mm; cat # 64952030; lot # unknown.Mrhk femoral bushing; cat # 64812110; lot # unknown.Mrhk femoral bushing; cat # 64812110; lot # unknown.Mrh axle; cat # 64812120; lot # unknown.Triathlon cemented stem-15mm x 100mm; cat # 5560-s-215; lot # unknown.Simplex p with tobramycin 1 pack; cat # 6197-9-001; lot # mga057.Mrh tibial b/plt keel med 2; cat # 64813112; lot # unknown mrhk tibial sleeve; cat # 64812140; lot # unknown.Mrh tib rot comp xs-xl; cat # 64812100; lot # unknown.Mrhk bumper insert 3 degrees; cat # 64812133; lot # unknown.Mrhk tib ins 10mm m/l m2/l2; cat # 64813310; lot # unknown.Triathlon sym cone aug sz e; cat # 5549-a-150; lot # unknown.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 infection involving a mrs stem 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: a review of the provided medical information by a clinical consultant indicated: "this patient unfortunately sustained one of the most serious complications in total knee arthroplasty.Not only does he have infection but the organism is a fungus which is very difficult to eradicate.Infection can persist despite what appears to be negative cultures.This is especially true for fungal infections.I can confirm that the patient had knee replacement surgery in 2017 with a zimmer implant because i was able to see the sticker sheet.I can confirm that he underwent a reimplantation in 2019 because i was able to review the operation report.The causes of periprosthetic infection are multifactorial.Infection in the early postoperative course can be due to wound contamination, wound healing problems with drainage and patient factors such as medical condition, nutritional state and possible immuno compromise.Early and late infections can be caused by contamination of the arthroplasty from a remote site causing infection.Why a patient develops a fungal infection is unclear.As noted above this is one of the most difficult types of infections to eradicate and it could result in amputation.I see no causation related to the use of stryker implants in this case." -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 is experiencing pain, limb length discrepancy, and loss of range of motion post-implantation of stryker components.The patient was previously diagnosed with a fungal infection (prior to implantation of stryker devices).A review of the provided medical information by a clinical consultant indicated: "this patient unfortunately sustained one of the most serious complications in total knee arthroplasty.Not only does he have infection but the organism is a fungus which is very difficult to eradicate.Infection can persist despite what appears to be negative cultures.This is especially true for fungal infections.I can confirm that the patient had knee replacement surgery in 2017 with a zimmer implant because i was able to see the sticker sheet.I can confirm that he underwent a reimplantation in 2019 because i was able to review the operation report.The causes of periprosthetic infection are multifactorial.Infection in the early postoperative course can be due to wound contamination, wound healing problems with drainage and patient factors such as medical condition, nutritional state and possible immuno compromise.Early and late infections can be caused by contamination of the arthroplasty from a remote site causing infection.Why a patient develops a fungal infection is unclear.As noted above this is one of the most difficult types of infections to eradicate and it could result in amputation.I see no causation related to the use of stryker implants in this case." all stryker products sold as sterile are validated to a minimum sterility assurance level sal of 10^-6 in accordance with applicable iso standards.Further information such as pathology reports, pre- and post-operative x-rays and the primary/revision operative reports as well as patient history and follow-up notes are needed to complete the investigation for determining root cause.Additionally, the patient is requesting if their implants are part of a recall.Based on the catalog number provided (lot code not provided), the reported device is not subject to a product recall.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 Description

Patient reported he had a left knee tka done on 1999 and was revised on 2017 due to pain and on 2019 (stryker implants) due to fungal infection.Patient is unsure if the 1999 and 2017 implants are stryker.Patient stated his pain never went away and over the last year the pain has become extreme.His rom has decreased to 45 degrees and has leg discrepancy, his left leg is shorted than his right leg.Patient is attending pain management.Patient would like to know if his implants are part of a recall.The patient would like assistance with his revision as this is his fourth revision and there's a risk of amputation.The patient would also like assistance with who will be the best surgeon to go to as he does not want to get amputated.Update 31-may-2022: "i have been experiencing increased pain walking on the left leg to point of pain of 10 on scale of 1 to 10, even with pain management.(percocet and lyrica twice a day and low dose valium at night to help sleep due to pain).I can only walk very short distances or stand for short periods of time.The meds do not eliminate the pain but help me to function.I am now disability retired as a result.The pain reached a very high level about 18 months ago but i was holding off due to the ¿return rate¿ of the infection.I had a very rare fungal infection with 2 to 3 cases a year in the u.S.Hss and mayo never had a case it is so rare.In the limited number of cases studied there was a 40% chance of reoccurrence in first two years, so they wanted to wait.I was tested back in feb 2022 for infection by drawing fluid from the knee.It came back negative.I am going to mention today to possibly repeat the test for infection to rule it out.The 3 phase bone scan showed periprosthetic uptake completely around the stem in the femur.The report stated it can be due to infection or loosening of hardware.I had included the sticker sheet from my second replacement in nov 2017 so i do know what to look for.I am going to call medical records and see if i can speak to a supervisor, even if they have to send all of my records for my hospital stay in dec 2019.".

• Brand Name: MRS FEM STEM W/0 BODY 15X127MM
• Type of Device: PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-LIMERICK; raheen business park; limerick NJ NA ; EI NA
• Manufacturer Contact: marisol santiago ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 14393179
• MDR Text Key: 291599164
• Report Number: 0002249697-2022-00695
• Device Sequence Number: 1
• Product Code: KRO
• UDI-Device Identifier: 07613327049374
• UDI-Public: 07613327049374
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K965164
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/10/2022

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 Model Number: 6485-3-115
• Device Catalogue Number: 64853115
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/21/2022
• Initial Date FDA Received: 05/13/2022
• Supplement Dates Manufacturer Received: 10/14/2022
• Supplement Dates FDA Received: 11/10/2022
• 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): Hospitalization
• Patient Age: 58 YR
• Patient Sex: Male
• Patient Weight: 118 KG