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

Catalog Number	5550-G-278
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	Injury (2348)
Date of Event	06/21/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Further investigation of the returned device is ongoing at this time.When a full investigation has been carried out a supplemental report will be made available.
Event or Problem Description
It was reported that the patient's right knee was revised due to a cracked cr insert.Patient was revised to a 13mm cs insert.
Additional Manufacturer Narrative
Reported event: an event regarding crack/fracture involving an triathlon insert was reported.Conclusion: based on the information provided there is no indication or allegation that the device reported in this investigation contributed to the event and is therefore considered concomitant.A material analysis has been performed.The report concluded: the damage on the articulating surface of the patella insert is consistent with contact against the femoral component.Based on the given information, no identifiable materials or manufacturing discrepancies were observed on the surfaces examined.No further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
It was reported that the patient's right knee was revised due to a cracked cr insert.Patient was revised to a 13mm cs insert.

• Brand Name: TRIATHLON SYMMETRIC 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
• MDR Report Key: 8960487
• Report Number: 0002249697-2019-03080
• Device Sequence Number: 19450515
• Product Code: MBH
• UDI-Device Identifier: 07613327014730
• UDI-Public: 07613327014730
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K141056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/02/2019

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: 12/31/2015
• Device Catalogue Number: 5550-G-278
• Device Lot Number: B724
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/08/2019
• Initial Date Received by Manufacturer: 08/08/2019
• Supplement Date Received by Manufacturer: 09/05/2019
• Initial Report FDA Received Date: 09/04/2019
• Supplement Report FDA Received Date: 10/02/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention