MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON PKR FEMUR #6 LM/RL; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Model Number	5610-F-601
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Ambulation or Postural Difficulties (2544)
Date of Event	12/15/2021
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.Device not returned to the manufacturer.
Event or Problem Description
The patient received a removal of the sled prosthesis due to aseptic loosening on (b)(6) 2021.During removal of the sled prosthesis, it was noticed that the femoral part was broken.
Additional Manufacturer Narrative
Reported event: an event regarding crack/fracture involving a triathlon femoral component was reported.The event was confirmed via evaluation of the returned device and through clinician review of provided medical records.Method & results: -product evaluation and results: visual inspection: the pka femoral component was returned.There is a layer of bone cement on the underside of the device.The device has fractured between the 2 pegs.The damage is consistent with fatigue accumulation ultimately ending in a fatigue fracture of the device requiring revision.-clinician review: a review of the provided medical information by a clinical consultant indicated: "this inquiry concerns a patient who underwent a medial compartment partial knee arthroplasty in 2010 and subsequently required revision surgery in 2021.Initially it was felt that revision was needed for tibial loosening.At the time of the revision, it was found that the femoral component was fractured.In my opinion, the femoral fracture could have been seen prior to the revision.It was present on the lateral x-ray provided.I can confirm that this event happened since i was able to see the x-ray and intraoperative photo showing the fractured femoral component.The loosening of the tibial component is less clear shown.The root cause of this event cannot be determined with certainty.Causes of aseptic loosening after 10 years are multifactorial.These include surgical technique factors and patient factors, including bmi and activity level.Causes of femoral component fracture are also multifactorial.Fracture can occur by fatigue if fixation was solid in one area and not in another.Surgical technique therefore can be contributory.In this particular case i saw very little cement if any anteriorly and no cement posteriorly on the femoral component.This possibly could cause a fatigue effect resulting in fracture." -product history review: could not be performed as the device lot details were not provided.-complaint history review: could not be performed as the device lot details were not provided.Conclusions: it was reported that the patient was revised due to tibial loosening, and, intraoperatively, fracture of the femoral component was observed.The pka femoral component was returned for evaluation.There is a layer of bone cement on the underside of the device.The device has fractured between the 2 pegs.The damage is consistent with fatigue accumulation ultimately ending in a fatigue fracture of the device requiring revision.A review of the provided medical information by a clinical consultant indicated "the femoral fracture could have been seen prior to the revision.It was present on the lateral x-ray provided.I can confirm that this event happened since i was able to see the x-ray and intraoperative photo showing the fractured femoral component.Causes of femoral component fracture are also multifactorial.Fracture can occur by fatigue if fixation was solid in one area and not in another.Surgical technique therefore can be contributory.In this particular case i saw very little cement if any anteriorly and no cement posteriorly on the femoral component.This possibly could cause a fatigue effect resulting in fracture." 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.
Event or Problem Description
The patient received a removal of the sled prosthesis due to aseptic loosening on (b)(6) 2021.During removal of the sled prosthesis, it was noticed that the femoral part was broken.

• Brand Name: TRIATHLON PKR FEMUR #6 LM/RL
• 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: arokiya raj ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 13569308
• Report Number: 0002249697-2022-00253
• Device Sequence Number: 3860655
• Product Code: MBH
• UDI-Device Identifier: 07613327027822
• UDI-Public: 07613327027822
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K071881
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/24/2022

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 Model Number: 5610-F-601
• Device Catalogue Number: 5610-F-601
• Device Lot Number: UNKNOWN
• 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: 01/27/2022
• Supplement Date Received by Manufacturer: 08/25/2022
• Initial Report FDA Received Date: 02/21/2022
• Supplement Report FDA Received Date: 09/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: 73 YR
• Patient Sex: Unknown
• Patient Weight: 106 KG