MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH NO 6. TRIATHLON TS PLUS TIBIAL INSERT X3 POLY 19MM; IMPLANT

Catalog Number 5537-G-619

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem No Code Available (3191)

Event Date 06/01/2015

Event Type  Injury  

Event Description

Dr.Reports patient, a status post right knee revision back on (b)(6) 2014, has posteriorly dislocated and dr.Would like to change the insert to a thicker one.Dr.(b)(6) proceeded to revise the insert.

Manufacturer Narrative

An evaluation of the device cannot be performed as the device was sent to pathology as per or protocol and 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 involving the revision of a triathlon ts 19mm insert to a thicker insert to a due to instability leading to posterior dislocation was reported.The event was confirmed.Method & results: device evaluation and results: not performed as the device was not returned for evaluation.Medical records received and evaluation: clinician review of the medical records provided indicated that multiple revision surgeries have caused knee ligament scar tissue formation contributing to late instability of the knee through gradual scar tissue relaxation requiring liner exchange for a thicker one.Device history review: indicated the device was manufactured and accepted into final stock with no reported discrepancies.Complaint history review: indicated that there have been no other similar reported events for the lot referenced.Conclusions: clinician review of the medical records provided indicated that multiple revision surgeries have caused knee ligament scar tissue formation contributing to late instability of the knee through gradual scar tissue relaxation requiring liner exchange for a thicker one.No further investigation is possible at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.A capa trend analysis was conducted for the reported failure mode and concluded instability may result from other factors not necessarily related to the device.

Event Description

Dr.Reports patient, a status post right knee revision back on (b)(6) 2014, has posteriorly dislocated and dr.Would like to change the insert to a thicker one.Dr.(b)(6) proceeded to revise the insert.

• Brand Name: NO 6. TRIATHLON TS PLUS TIBIAL INSERT X3 POLY 19MM
• 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: 4863989
• MDR Text Key: 19034238
• Report Number: 0002249697-2015-02048
• 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

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2019
• Device Catalogue Number: 5537-G-619
• Device Lot Number: MNNR77
• Other Device ID Number: STERILE LOT: MSGN11D1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/10/2015
• Initial Date FDA Received: 06/23/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/03/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/13/2014
• 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: 56 YR
• Patient Weight: 148