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

Model Number 5532-G-509

Device Problems Break (1069); Fracture (1260)

Patient Problems Ambulation Difficulties (2544); Insufficient Information (4580)

Event Date 07/20/2021

Event Type  Injury  

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.

Event Description

It was reported that the patient's right knee was revised.Patient reported he had been kneeling or squatting and felt the knee give.Intra-operatively, the post of the ps insert was found to have broken.The insert was exchanged.Rep has the device available for return and can provide pictures.Rep confirmed the surgeon wants investigation results, and that no further information will be released by the hospital or surgeon.

Manufacturer Narrative

Reported event: an event regarding crack/fracture involving a triathlon insert was reported.The event was confirmed via evaluation of the returned device.Method & results: product evaluation and results: visual inspection: visual inspection indicated that the damage present on the post of the insert was consistent with delamination and material loss.The post has completely fractured off.Hackles are observed on the fractured surface are consistent with a fracture in overload.The damage on the articulating surface of the insert is consistent with burnishing, scratching, and third body indentations; which are common damage modes of uhmwpe.The yellow discoloration observed on the tibial insert is consistent with the absorption of synovial fluid by the device.Clinician review: a review of the provided medical information by a clinical consultant indicated: "material reviewed: 07/21/2021: stryker pi report.Unlabeled/undated x-ray lateral knee.¿11 yrs out¿.No gross abn cemented primary triathlon.Unlabeled/undated x-ray ap standing knee.N o gross abn.Triathlon primary.Confirmation: the event cannot be confirmed without additional clinical and operative records.Root cause: a root cause cannot be ascertained as the event cannot be confirmed.If in fact the ps post fractured, clinical information would be helpful to assess for increased stresses placed on the plastic for example was the knee unstable or hyperextensible." product 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 lot referenced.Conclusions: it was reported that the patient was revised due to fracture of the triathlon insert.Visual inspection indicated that the damage present on the post of the insert was consistent with delamination and material loss.The post has completely fractured off.Hackles are observed on the fractured surface are consistent with a fracture in overload.The damage on the articulating surface of the insert is consistent with burnishing, scratching, and third body indentations; which are common damage modes of uhmwpe.The yellow discoloration observed on the tibial insert is consistent with the absorption of synovial fluid by the device.A review of the provided medical information by a clinical consultant indicated: "the event cannot be confirmed without additional clinical and operative records.Root cause: a root cause cannot be ascertained as the event cannot be confirmed.If in fact the ps post fractured, clinical information would be helpful to assess for increased stresses placed on the plastic for example was the knee unstable or hyperextensible." 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 Description

It was reported that the patient's right knee was revised.Patient reported he had been kneeling or squatting and felt the knee give.Intra-operatively, the post of the ps insert was found to have broken.The insert was exchanged.Rep has the device available for return and can provide pictures.Rep confirmed the surgeon wants investigation results, and that no further information will be released by the hospital or surgeon.

• Brand Name: TRIATHLON PS X3 TIBIAL INSERT
• 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-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer Contact: marisol santiago ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 12306309
• MDR Text Key: 265970559
• Report Number: 0002249697-2021-01358
• Device Sequence Number: 1
• Product Code: MBH
• UDI-Device Identifier: 07613327050776
• UDI-Public: 07613327050776
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K141056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/15/2022

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
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2015
• Device Model Number: 5532-G-509
• Device Catalogue Number: 5532-G-509
• Device Lot Number: MJK547
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/28/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/20/2021
• Initial Date FDA Received: 08/11/2021
• Supplement Dates Manufacturer Received: 10/24/2022
• Supplement Dates FDA Received: 11/15/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/14/2010
• 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: 81 YR
• Patient Sex: Male
• Patient Weight: 107 KG