MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON PS X3 TIBIAL INSERT; IMPLANT

Catalog Number 5532-G-413

Device Problem Material Too Rigid or Stiff (1544)

Patient Problems Muscular Rigidity (1968); Loss of Range of Motion (2032)

Event Date 06/01/2015

Event Type  Injury  

Event Description

Patient had a left knee revision due to patient complaining of not getting full flexion and having tightness in the knee joint.Surgeon replaced patient's 13mm insert with an 11mm insert.All other components were well fixed with no issues.

Manufacturer Narrative

An event regarding stiffness leading to revision surgery involving a triathlon insert component was reported.The event was not confirmed.Method & results: -device evaluation and results: not performed as no product was returned for evaluation.-medical records received and evaluation: not performed as no medical records were received.-device history review: dhr review was satisfactory.-complaint history review: chr review confirmed that there were no other similar events reported for the lot.Conclusions: the reported event cannot be confirmed with the information provided.The exact cause of the event could not be determined with the limited information provided.Further information such as x-rays, operative reports, patient history and follow-up notes are needed to complete the investigation for determining root cause.No further investigation for this event is possible at this time.If the device or additional information becomes available, this investigation will be reopened.

Event Description

Patient had a left knee revision due to patient complaining of not getting full flexion and having tightness in the knee joint.Surgeon replaced patient's 13mm insert with an 11mm insert.All other components were well fixed with no issues.

Manufacturer Narrative

An evaluation of the device cannot be performed as the device was retained by the hospital 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.

• Brand Name: TRIATHLON PS X3 TIBIAL INSERT
• Type of Device: IMPLANT
• 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: 4863998
• MDR Text Key: 6322652
• Report Number: 0002249697-2015-02051
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/01/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2018
• Device Catalogue Number: 5532-G-413
• Device Lot Number: MMP4XN
• Other Device ID Number: STERILE LOT: MSGMP31J4
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/10/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2013
• 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): Required Intervention
• Patient Age: 51 YR
• Patient Weight: 105