MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON CR X3 TIBIAL INSERT; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Model Number	5530-G-413
Medical Device Problem Codes	Fracture (1260); Naturally Worn (2988)
Health Effect - Clinical Codes	Ambulation or Postural Difficulties (2544); Insufficient Information (4580)
Date of Event	12/09/2021
Type of Reportable Event	Serious Injury
Additional 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 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.Device not returned.
Event or Problem Description
It has been reported "sudden locking in knee.Very active patient.Wear of poly posterior".
Additional Manufacturer Narrative
Reported event: an event regarding crack/fracture involving a triathlon insert was reported.The event was confirmed via product evaluation.Method & results: -device evaluation and results: visual inspection: visual inspection of the returned device confirms that the device was fractured/damaged at a posterior edge which is consistent with articulation against hard object.Explantation damage was also observed on the insert.Dimensional inspection: not performed as the device was returned damaged.Functional inspection: not performed as the device was returned damaged.Material analysis: a visual of the product did not identify any material integrity or manufacturing issue.If further information becomes available additional testing will be performed.-clinician review: a review of medical records with a clinical consultant indicated " revision surgery for posterior subluxation of the femoral component in relation to the tibial component is confirmed.The surgeons notes state "very active patient with functioning process then sudden posterior dislocation".Postoperative x-rays demonstrate posterior subluxation of the femoral component in relation to the tibial component.I can not confirm "posterior wear" as operative findings were not described in the portions of the operative report.The root cause for the posterior subluxation can not be discerned from the limited information provided." -device 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 reported lot.Conclusion: it was reported that the patient was revised due to wear of poly posterior.Visual inspection of the returned device confirms that the device was fractured/damaged at a posterior edge which is consistent with articulation against hard object.Explantation damage was also observed on the insert.A visual of the product did not identify any material integrity or manufacturing issue.A review of medical records with a clinical consultant indicated " revision surgery for posterior subluxation of the femoral component in relation to the tibial component is confirmed.The surgeons notes state "very active patient with functioning process then sudden posterior dislocation".Postoperative x-rays demonstrate posterior subluxation of the femoral component in relation to the tibial component.I can not confirm "posterior wear" as operative findings were not described in the portions of the operative report.The root cause for the posterior subluxation can not be discerned from the limited information provided." the exact cause of the event cannot be determined from the information provided.No further investigation for this event is possible at this time.If additional information become available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
It has been reported "sudden locking in knee.Very active patient.Wear of poly posterior".

• Brand Name: TRIATHLON CR X3 TIBIAL INSERT
• 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-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer Contact: diana rogers ; 210 centennial avenue; centennial park, elstree; borehamwood WD6 3-SJ ; UK WD6 3SJ ; 2082386500
• MDR Report Key: 13652050
• Report Number: 0002249697-2022-00309
• Device Sequence Number: 19443554
• Product Code: MBH
• UDI-Device Identifier: 07613327050509
• UDI-Public: 07613327050509
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: K141056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/03/2022

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: 04/30/2020
• Device Model Number: 5530-G-413
• Device Catalogue Number: 5530-G-413
• Device Lot Number: 1L828W
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 07/18/2022
• Initial Report FDA Received Date: 03/02/2022
• Supplement Report FDA Received Date: 08/03/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/22/2015
• 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: 61 YR
• Patient Sex: Female
• Patient Weight: 85 KG