MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH NO 4. TRIATHLON TS PLUS TIBIAL INSERT X3 POLY 22MM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number 5537-G-422

Device Problems Device Dislodged or Dislocated (2923); Insufficient Information (3190)

Patient Problems Damage to Ligament(s) (1952); Injury (2348)

Event Date 09/29/2016

Event Type  Injury  

Manufacturer Narrative

The following devices were also listed in this report: tri press-fit stem 22mm x 100mm; cat# 5565-s-022; lot# m8l14a.Triathlon total knee system offset adapter 4mm; cat# 5570-s-040; lot# 0036732k.Tri post augment sz4 5mm; cat# 5543-a-400; lot# tw4z, qty.2.Triathlon femoral distal augment 10mm - size 4 left; cat# 5541-a-401; lot# u4ya.Triathlon femoral distal augment 5mm - size 4 left; cat# 5540-a-401; lot# iiye.Tri ts femur sz4 left; cat# 5512-f-401; lot# utvv.Tri press-fit stem 18mm x 100mm; cat# 5565-s-018; lot# m9a15a.Tri ts baseplate size 4; cat# 5521-b-400; lot# vg4ea.Triathlon total knee system offset adapter 6mm; cat# 5570-s-060; lot# m7t51l.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.An evaluation of the device cannot be performed as the device was not returned to the manufacturer due to hospital policy.Additional information has been requested.Should additional information become available it will be reported in a supplemental report upon completion of the investigation.Not returned to the manufacturer.

Event Description

Patient underwent a revision of a competitor total knee on (b)(6) with a stryker ts.Operation was completed successfully.Patient subsequently tore his lateral collateral ligament and dislocated.It was determined that he would need a hinged component for stability.He was successfully revised on (b)(6).

Manufacturer Narrative

An event regarding dislocation involving a triathlon insert was reported.The event was not confirmed.Method & results: -device evaluation and results: not performed as the reported product was not returned.-medical records received and evaluation: review of medical records by a consulting clinician noted: "undated x-ray does not confirm event, need operative reports, clinical and past medical history, need dated x-rays and examination of explanted components." -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: the exact cause of the event could not be determined due to insufficient provision of information.Event notes that patient tore his lateral collateral ligament, which could have led to dislocation.Further information such as: return of reported devices, x-rays, operative reports as well as patient history and follow up notes are needed to complete the investigation to determine root cause.No further investigation is possible at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.

Event Description

Patient underwent a revision of a competitor total knee on (b)(6) with a stryker ts.Operation was completed successfully.Patient subsequently tore his lateral collateral ligament and dislocated.It was determined that he would need a hinged component for stability.He was successfully revised on (b)(6).

• Brand Name: NO 4. TRIATHLON TS PLUS TIBIAL INSERT X3 POLY 22MM
• 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: cindy chuhinko ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6059859
• MDR Text Key: 58464825
• Report Number: 0002249697-2016-03378
• 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: 01/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2021
• Device Catalogue Number: 5537-G-422
• Device Lot Number: YH8JW6
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/08/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/30/2016
• 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: 61 YR
• Patient Weight: 75