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
Medical Device Problem Codes	Break (1069); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Fall (1848); Ambulation or Postural Difficulties (2544); Muscle/Tendon Damage (4532); Insufficient Information (4580)
Date of Event	06/30/2021
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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 or Problem 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.".
Additional 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
• 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: diana rogers ; 210 centennial avenue; centennial park, elstree; borehamwood, NJ WD6 3-SJ ; UK WD6 3SJ ; 2018315000
• MDR Report Key: 13618862
• Report Number: 0002249697-2022-00293
• Device Sequence Number: 5706399
• Product Code: MBH
• UDI-Device Identifier: 07613327336504
• UDI-Public: 07613327336504
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K172634
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/20/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2024
• 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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/04/2022
• Supplement Date Received by Manufacturer: 04/27/2022
• Initial Report FDA Received Date: 02/28/2022
• Supplement Report FDA Received Date: 05/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/30/2019
• 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: Required Intervention; Hospitalization
• Patient Age: 67 YR
• Patient Sex: Female
• Patient Weight: 63 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White