MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH X3 TRIATHLON CS INS SIZE1 9MM; IMPLANT

Catalog Number 5531G109

Device Problems Sticking (1597); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Loss of Range of Motion (2032); Limited Mobility Of The Implanted Joint (2671)

Event Date 06/03/2015

Event Type  Injury  

Event Description

Tka was performed about a year ago.The patient experienced loss of motion.

Manufacturer Narrative

An evaluation of the device cannot be performed as the device was not returned to the manufacturer.Additional information pertaining to the device referenced in this report has been requested.Should additional information become available it will be reported in a supplemental report upon completion of the investigation.

Manufacturer Narrative

An event regarding arthrofibrosis involving a triathlon insert was reported.The event was confirmed based on medical review.Method & results: device evaluation and results: not performed as no items were returned.Photos of the explanted device appear unremarkable.Medical records received and evaluation: medical review of this case indicated: multiple previous surgical procedures prior to knee arthroplasty have contributed to significantly increased risk on arthrofibrosis after tka which was adequately treated by liner exchange.Device history review: there were no reported discrepancies for the referenced lot.Complaint history review: there have been no other similar events for the lot referenced.Conclusions: the medical review indicated that there was no information to suggest that device-related aspects have played any role as also supported by the visual findings of the explant.From the patient-related perspective there is little information, at least body weight was not really excessive with a bmi of 29 and as such not relevant.Multiple prior surgery is the dominant failure cause for this case and this is patient-related in origin.This pi case is not device-related.A capa trend analysis was conducted for the reported failure mode and concluded that arthrofibrosis may result from other factors not necessarily related to the device.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 Description

Tka was performed about a year ago.The patient experienced loss of motion.

• Brand Name: X3 TRIATHLON CS INS SIZE1 9MM
• Type of Device: IMPLANT
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-LIMERICK (MDR); raheen business park; limerick NA
• Manufacturer Contact: william hanna ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 4869780
• MDR Text Key: 5863146
• Report Number: 0002249697-2015-02106
• 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: Other,Health Professional,health professional,oth
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/03/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/25/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2016
• Device Catalogue Number: 5531G109
• Device Lot Number: LCK583
• Other Device ID Number: STERILE LOT: M5X85
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/23/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/31/2011
• 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): Required Intervention
• Patient Age: 24 YR
• Patient Weight: 91