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

Catalog Number 5532-G-409

Device Problems Device Operates Differently Than Expected (2913); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Scar Tissue (2060); Injury (2348)

Event Date 11/03/2015

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Patient was not able to get out to full extension due to massive amount of scar tissue.This is a left knee.

Manufacturer Narrative

An event regarding arthrofibrosis and a resulting limited range of motion involving a triathlon ps x3 tibial insert was reported.The event was confirmed by the revision operative report.Method & results: -device evaluation and results: could not be performed as no items associated with the event were returned or made available for evaluation.-medical records received and evaluation: a review of the provided medical records and/or x-rays by a clinical consultant concluded: "combining all facts and findings discussed, principal failure mode of this case is procedure-related as caused by arthrofibrosis of the arthroplasty post primary surgery.The bearing was exchanged in combination with extensive debridement and scar tissue removal.No information to suggest that device-related aspects have played any role which is consistent with the type of problem reported.From the patient-related perspective there is little information, at least body weight was not really excessive with a bmi of 31 and as such is not relevant.This pi case is not device-related.-device history review: the reported device was manufactured and accepted into final stock with no reported discrepancies.-complaint history review: there have been no other similar events reported for this manufacturing lot.Conclusions: the exact root cause could not be determined.A review of the provided records by a clinical consultant indicated there is no evidence the event is device related.A capa trend analysis was conducted for the reported failure mode and concluded arthrofibrosis may result from other factors not necessarily related to the device.No further investigation for this event is possible at this time as no devices were received for evaluation.If devices become available, this investigation will be reopened.

Event Description

Patient was not able to get out to full extension due to massive amount of scar tissue.This is a left knee.

• 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: beverly lima ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 5240042
• MDR Text Key: 31748993
• Report Number: 0002249697-2015-03965
• 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: 11/03/2015

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: 07/31/2019
• Device Catalogue Number: 5532-G-409
• Device Lot Number: MNL2H7
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/03/2015
• Initial Date FDA Received: 11/20/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/20/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/04/2014
• 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: 49 YR
• Patient Weight: 81