MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH X3 TRIATHLON CS INSERT #5 13MM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, C

Catalog Number 5531G513

Device Problems Material Distortion (2977); Scratched Material (3020); Insufficient Information (3190)

Patient Problem Injury (2348)

Event Date 07/10/2017

Event Type  Injury  

Manufacturer Narrative

Review of the device history records indicate devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other similar events for the lot referenced.A supplemental report will be submitted upon completion of the investigation.Not available.

Event Description

It was reported that a patient complained of instability of knee.Surgeon scheduled a poly exchange to increase the thickness of the insert.Initial insert was removed and revised with a #5 16mm cs insert.

Manufacturer Narrative

An event regarding instability involving an triathlon insert was reported.The event was confirmed through medical records.Device evaluation and results: material analysis concludes burnishing, scratching and third-body indentations were observed on the insert.These are common damage modes of uhmwpe.No material or manufacturing defects were observed on the surfaces examined.Medical records received and evaluation: a high posterior tibial slope of 9° in combination with a low tibial bone resection, required for correction of preoperative knee deformity, has contributed to pcl damage with instability in both flexion and extension with the overload condition further increased by obesity and a very high activity level of the patient.It is also noted that the patient presented with a varus deformity of knee prior to arthroplasty requiring a lower than normal tibial bone resection.Device history review: device history review indicated the devices were accepted into final stock with no reported discrepancies.Complaint history review: there has been no other event for the lot referenced.Conclusions: it was reported that patient was revised due to instability.The results of the investigation indicate a high posterior tibial slope of 9° in combination with a low tibial bone resection, required for correction of preoperative knee deformity, has contributed to pcl damage with instability in both flexion and extension with the overload condition further increased by obesity and a very high activity level of the patient.It is also noted that the patient presented with a varus deformity of knee prior to arthroplasty requiring a lower than normal tibial bone resection.Material analysis of the explanted device concludes burnishing, scratching and third-body indentations were observed on the insert.These are common damage modes of uhmwpe.No material or manufacturing defects were observed on the surfaces examined.No further investigation is possible at this time.If additional information are received, this investigation will be reopened and re-evaluated.

Event Description

It was reported that a patient complained of instability of knee.Surgeon scheduled a poly exchange to increase the thickness of the insert.Initial insert was removed and revised with a #5 16mm cs insert.

• Brand Name: X3 TRIATHLON CS INSERT #5 13MM
• Type of Device: PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, C
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-LIMERICK; raheen business park; limerick NA
• Manufacturer Contact: brian lauro ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6771026
• MDR Text Key: 81946701
• Report Number: 0002249697-2017-02384
• Device Sequence Number: 1
• Product Code: MBH
• 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: health professional,other
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/08/2017

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: 09/28/2013
• Device Catalogue Number: 5531G513
• Device Lot Number: LBF705
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/14/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/10/2017
• Initial Date FDA Received: 08/07/2017
• Supplement Dates Manufacturer Received: 10/11/2017
• Supplement Dates FDA Received: 11/08/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/28/2008
• 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: 66 YR
• Patient Weight: 111