MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH X3 TRIATHLON CS INSERT #2 11MM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Model Number 5531-G-211-E

Device Problems Break (1069); Insufficient Information (3190)

Patient Problems Fall (1848); Ambulation Difficulties (2544); Muscle/Tendon Damage (4532); Insufficient Information (4580)

Event Date 06/30/2021

Event Type  Injury  

Manufacturer Narrative

Review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other similar events for the lot referenced.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.

Event Description

Patient had a index rtka in (b)(6) 2021.Patient had a trauma and developed a disruption of the extensor mechanism that required revision on (b)(6) 2021.Only the poly component was exchanged.

Event Description

Patient had a index rtka in (b)(6)2021.Patient had a trauma and developed a disruption of the extensor mechanism that required revision on (b)(6)2021.Only the poly component was exchanged.Update 26-april-2022 per clinician review: "pre-revision x-rays show the cementless triathlon implant.The patella is extremely high riding consistent with a rupture of the patella tendon.[.] the procedure performed was ¿ right knee single component revision and secondary reconstruction of the right knee patella tendon with mesh augmentation¿.In the indications portion it states [.] that the patient suffered a ¿mechanical slip and fall".There was a small avulsion of the tibial tubercle.It states that there was a "notch" in the polyethylene which was attributed to the fall.Reconstruction was carried out using mesh and cement and a screw.".

Manufacturer Narrative

Reported event: an event regarding crack/fracture and patient factors (patella tendon rupture) involving a triathlon insert was reported.The patient factors (patella tendon rupture) event was confirmed; the crack/fracture event was not confirmed.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: "conclusion of assessment: this inquiry reports the complication of a rupture of the patella tendon after total knee arthroplasty.How soon after surgery is unclear due to discrepancies noted above.I can confirm that this event took place since i was able to view the pre-op and post-op radiographs and the index and revision operation report.However, no patient identifier is on the operation reports because they were redacted.Regarding the possible root cause of this event, i cannot determine it with certainty.Causes of patella tendon rupture after total knee replacement are multifactorial including trauma, patient activity factors and possible damage to the tendon at surgery." 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 no other similar events for the lot referenced.Conclusions: it was reported that the patient underwent surgery for the repair of a ruptured patella tendon following a slip and fall incident.Intraoperatively, the triathlon insert was revised as it was observed to have a "notch" in it.A review of the provided medical records by a clinical consultant confirmed the patella tendon rupture event but was unable to determine root cause: "this inquiry reports the complication of a rupture of the patella tendon after total knee arthroplasty.[.] i can confirm that this event took place since i was able to view the pre-op and post-op radiographs and the index and revision operation report.[.] regarding the possible root cause of this event, i cannot determine it with certainty.Causes of patella tendon rupture after total knee replacement are multifactorial including trauma, patient activity factors and possible damage to the tendon at surgery." return of the device and/or photographs of the event are required to confirm the reported crack/fracture of the insert.No further investigation for this event is possible at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.

• Brand Name: X3 TRIATHLON CS INSERT #2 11MM
• 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 NA ; EI NA
• Manufacturer Contact: diana rogers ; 210 centennial avenue; centennial park, elstree; borehamwood, NJ WD6 3-SJ ; UK WD6 3SJ ; 2018315000
• MDR Report Key: 13618862
• MDR Text Key: 286236633
• Report Number: 0002249697-2022-00293
• Device Sequence Number: 1
• Product Code: MBH
• UDI-Device Identifier: 07613327336504
• UDI-Public: 07613327336504
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K172634
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 5531-G-211-E
• Device Catalogue Number: 5531-G-211-E
• Device Lot Number: LJM958
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/27/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/30/2019
• 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
• Patient Age: 67 YR
• Patient Sex: Female
• Patient Weight: 63 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White