MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON CR FEM COMP #5 L-CEM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Model Number 5510-F-501

Device Problems Unstable (1667); Loss of Osseointegration (2408)

Patient Problems Pain (1994); Inadequate Osseointegration (2646); Joint Laxity (4526); Swelling/ Edema (4577)

Event Date 07/19/2022

Event Type  Injury  

Event Description

Patient's wife reported her husband had a primary left knee arthroplasty on (b)(6) 2021 and is scheduled for a revision surgery on august 1, 2022.It was reported that patient has been experiencing constant pain and swelling and feeling of "loosening".Audible noise was also reported.Patient would like to know if implants are subject to a recall.

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

Reported event: an event regarding instability involving a triathlon femoral component was reported.The event was confirmed via clinician review of provided medical records.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: a review of the provided medical information by a clinical consultant indicated: "the records reflect that he continued to have ongoing pain and at 7 months post op the surgeon notes his motion to be 0-115 but now notes that he has laxity which coincides with the patient's complaints of instability.He was referred to physical therapy for quad strengthening.He was seen in follow up 2 months later with no improvement.The surgeon diagnosed an unstable failed tka and revision surgery was planned.On (b)(6)2022 the patients primary femoral component was explanted and revised to a stemmed , coned ts femoral component and the x3 poly was exchanged to a ts insert as well.The surgeon noted that following the exchange the patient achieved full extension and easily flexed to 120.The knee was completely stable throughout the full arc of motion.Failed left tka secondary to instability is confirmed as is revision to a more constrained construct.The root cause for this failure cannot be determined from the documentation provided.The additional recorde did not provide any insight in to the cause of the patient's knee instability" -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 consistent pain and joint laxity.A review of the provided medical information by a clinical consultant indicated: "the records reflect that he continued to have ongoing pain and at 7 months post op the surgeon notes his motion to be 0-115 but now notes that he has laxity which coincides with the patient's complaints of instability.He was referred to physical therapy for quad strengthening.He was seen in follow up 2 months later with no improvement.The surgeon diagnosed an unstable failed tka and revision surgery was planned.On (b)(6)2022 the patients primary femoral component was explanted and revised to a stemmed , coned ts femoral component and the x3 poly was exchanged to a ts insert as well.The surgeon noted that following the exchange the patient achieved full extension and easily flexed to 120.The knee was completely stable throughout the full arc of motion.Failed left tka secondary to instability is confirmed as is revision to a more constrained construct.The root cause for this failure cannot be determined from the documentation provided.The additional recorde did not provide any insight in to the cause of the patient's knee instability." it was also reported that the patient is inquiring if their devices are part of a recall.Device lot code is required to determine if the reported device is 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.Correction: manufacturing site for devices(g1) the following devices were also listed in this report: device name#triathlon cr x3 tibial insert ; cat#5530-g-509-e ; lot#unknown.Device name#triathlon prim cem fxd bplt #5 ; cat#5520b500 ; lot#unknown.Device name#triathlon asymmetric x3 patella ; cat#5551-g-381-e ; lot#unknown.Device name#simplex p with tobramycin 1 pack ; cat#6197-9-001 ; lot#unknown.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.

Event Description

Patient's wife reported her husband had a primary left knee arthroplasty on (b)(6), 2021 and is scheduled for a revision surgery on (b)(6), 2022.It was reported that patient has been experiencing constant pain and swelling and feeling of "loosening".Audible noise was also reported.Patient would like to know if implants are subject to a recall.Update (b)(6) 2022 mf: revision surgery took place on (b)(6), 2022.The insert and femoral component were revised to "convert the patient to a more constrained design." the patient was revised to an augmented ts construct with stem.No damage, malposition, or loosening of the revised femoral component or insert were reported in the op notes.The baseplate was not revised as it was "in adequate alignment and well-fixed." it was also reported that the patient underwent manipulation under anesthesia to address reduced range of motion on an unknown date prior to the revision surgery.

• Brand Name: TRIATHLON CR FEM COMP #5 L-CEM
• 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-LIMERICK; raheen business park; limerick NJ NA ; EI NA
• Manufacturer Contact: arokiya raj ; 325 corporate drive; centennial park, elstree; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 15203152
• MDR Text Key: 297680088
• Report Number: 0002249697-2022-01156
• Device Sequence Number: 1
• Product Code: MBH
• UDI-Device Identifier: 07613327040296
• UDI-Public: 07613327040296
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K040267
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 5510-F-501
• Device Catalogue Number: 5510F501
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/31/2022
• 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; Required Intervention
• Patient Age: 56 YR
• Patient Sex: Male
• Patient Weight: 104 KG