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

Model Number	5551-G-299
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Fall (1848)
Date of Event	02/09/2021
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.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.Device not returned.
Event or Problem Description
The following was reported: patella broke after patient fell.
Additional Manufacturer Narrative
Reported event: an event regarding crack/fracture involving a triathlon patella was reported.The event was confirmed through material analysis evaluation of the returned device.Method & results:  -device evaluation and results: visual inspection was performed as part of the material analysis report (mar).This inspection indicated: overview photos of the returned device shows the fracture surface of one of the two posts on the lateral side.Photos show the damage seen on the medial side.Close up photos show the hackles that are evidence of overload fracture in the ultra-high molecular weight polyethylene plastic material.A material analysis has been performed.The report concluded: all the damage to the device is consistent with overload fractures.The fractures to the two posts on the lateral side are consistent with a fall that the patient incurred.The damage to the medial side is also consistent with a fall creating an impact to the surface against a harder object.Some of the damage seen to the flange area may be due to contact with hard surgical tooling during explantation.No defects in the material were found, nor any indications of manufacturing nonconformances.-clinician review: no medical records were received for review with a clinical consultant.-device history review: review of the device history records indicate the 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.Conclusion: visual inspection was performed as part of the material analysis report (mar).This inspection indicated: overview photos of the returned device shows the fracture surface of one of the two posts on the lateral side.Photos show the damage seen on the medial side.Close up photos show the hackles that are evidence of overload fracture in the ultra-high molecular weight polyethylene plastic material.A material analysis has been performed.The report concluded: all the damage to the device is consistent with overload fractures.The fractures to the two posts on the lateral side are consistent with a fall that the patient incurred.The damage to the medial side is also consistent with a fall creating an impact to the surface against a harder object.Some of the damage seen to the flange area may be due to contact with hard surgical tooling during explantation.No defects in the material were found, nor any indications of manufacturing nonconformances.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
The following was reported: patella broke after patient fell.

• Brand Name: TRIATHLON ASYMMETRIC X3 PATELLA
• 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: anna ryan ; raheen business park; limerick NA ; EI NA ; 61498200
• MDR Report Key: 11421065
• Report Number: 0002249697-2021-00381
• Device Sequence Number: 3243075
• Product Code: MBH
• UDI-Device Identifier: 07613327014792
• UDI-Public: 07613327014792
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: K141056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• 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: 05/31/2023
• Device Model Number: 5551-G-299
• Device Catalogue Number: 5551-G-299
• Device Lot Number: P4MP
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/09/2021
• Supplement Date Received by Manufacturer: 04/25/2022
• Initial Report FDA Received Date: 03/05/2021
• Supplement Report FDA Received Date: 05/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/31/2018
• 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: Hospitalization; Required Intervention
• Patient Age: 52 YR
• Patient Sex: Female