MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON MB PATELLA PA A38; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Model Number 5554-L-381

Device Problems Detachment of Device or Device Component (2907); Device Dislodged or Dislocated (2923)

Patient Problem Pain (1994)

Event Date 05/24/2023

Event Type  Injury  

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.

Event Description

It was reported that the patient's left knee was revised.After bumping his knee on his tractor (date of incident unknown), patient experienced chronic pain in the knee.Upon scoping the knee, the poly portion of the cemented metal-backed patella was found to be separated from the metal portion.The patellar component and insert were revised.

Manufacturer Narrative

Reported event: an event regarding crack/fracture involving a triathlon patella was reported.The event was confirmed based on medical review.Method & results: -device 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 records by a clinical consultant stated the following comment: according to the product inquiry summary, this patient underwent a primary cementless total knee arthroplasty in 2013.In 2023 he required revision surgery after an arthroscopic procedure revealed the polyethylene component of a "cemented" patella component had "separated." this required revision of the patella component and insert.The root cause of this event cannot be determined with certainty.I have questions about the description of this event.The original operation report states that the procedure was done in a cementless fashion and makes no mention of cementing of the patella component.However this event related to de-bonding of polyethylene component from a cemented metal backed patella.This needs to be clarified with the surgeon.The product grid stated that the patella component was a triathlon metal backed pa patella.If that is the case it is not meant to be cemented.Again this must be clarified with the surgeon.The causes of debonding of the polyethylene of a cemented patella are multifactorial.These include surgical technique factors, patient factors including activity level and bmi, and implant factors.If in fact the patella was cemented and was not approved for cemented use, this could contribute to abnormal stresses which could contribute to debonding and separation.In my opinion, a mere bump on the knee would not contribute significantly to the debonding.In any event, the implant itself should be submitted to stryker engineers for evaluation and examination.Without that being done, no causality could be assigned to the implant itself.-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 reported lot.Conclusion: it was reported that the patient was revised due to the poly portion of the cemented metal-backed patella was found to be separated from the metal portion.The event was confirmed based based on medical review.A review of the provided medical records by a clinical consultant stated the following comment: "according to the product inquiry summary, this patient underwent a primary cementless total knee arthroplasty in 2013.In 2023 he required revision surgery after an arthroscopic procedure revealed the polyethylene component of a "cemented" patella component had "separated." this required revision of the patella component and insert.The root cause of this event cannot be determined with certainty.I have questions about the description of this event.The original operation report states that the procedure was done in a cementless fashion and makes no mention of cementing of the patella component.However this event related to de-bonding of polyethylene component from a cemented metal backed patella.This needs to be clarified with the surgeon.The product grid stated that the patella component was a triathlon metal backed pa patella.If that is the case it is not meant to be cemented.Again this must be clarified with the surgeon.The causes of debonding of the polyethylene of a cemented patella are multifactorial.These include surgical technique factors, patient factors including activity level and bmi, and implant factors.If in fact the patella was cemented and was not approved for cemented use, this could contribute to abnormal stresses which could contribute to debonding and separation.In my opinion, a mere bump on the knee would not contribute significantly to the debonding.In any event, the implant itself should be submitted to stryker engineers for evaluation and examination.Without that being done, no causality could be assigned to the implant itself." the exact cause of the event could not be determined because insufficient information was provided.Additional information including return of the device are needed to fully investigate the event.If further information becomes available or the product is returned, this investigation will be re-opened.H3 other text : device not returned.

Event Description

It was reported that the patient's left knee was revised.After bumping his knee on his tractor (date of incident unknown), patient experienced chronic pain in the knee.Upon scoping the knee, the poly portion of the cemented metal-backed patella was found to be separated from the metal portion.The patellar component and insert were revised.

• Brand Name: TRIATHLON MB PATELLA PA A38
• Type of Device: 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: anna ryan ; raheen business park; centennial park, elstree; limerick WD6 3-SJ ; EI WD6 3SJ ; 61498200
• MDR Report Key: 17151115
• MDR Text Key: 317452689
• Report Number: 0002249697-2023-00689
• Device Sequence Number: 1
• Product Code: MBH
• UDI-Device Identifier: 07613327049916
• UDI-Public: 07613327049916
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K061521
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/20/2023

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
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2018
• Device Model Number: 5554-L-381
• Device Catalogue Number: 5554L381
• Device Lot Number: EDNEK
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/24/2023
• Initial Date FDA Received: 06/19/2023
• Supplement Dates Manufacturer Received: 06/27/2023
• Supplement Dates FDA Received: 07/20/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/15/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 73 YR
• Patient Sex: Male