MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH NO 6. TRIATHLON TS PLUS TIBIAL INSERT X3 POLY 16MM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number 5537-G-616

Device Problems Break (1069); Fracture (1260); Device Contamination with Chemical or Other Material (2944); Material Integrity Problem (2978)

Patient Problems Injury (2348); No Known Impact Or Consequence To Patient (2692)

Event Date 09/13/2016

Event Type  Injury  

Manufacturer Narrative

It was noted that the device is not available for evaluation.Additional information has been requested and if received, will be provided in the supplemental report upon completion of the investigation.

Event Description

A wire shaped meal foreign body in the lat.Dorsal knee was observed.No complaints from the patient.

Manufacturer Narrative

Corrected data: product returned.An event regarding crack/fracture involving a triathlon insert was reported.The event was confirmed.Method & results: device evaluation and results: visual inspection was performed as part of the material analysis report (mar), dated 13-jan-2017.The anterior, posterior, articulating, and distal surfaces of the insert were examined.The parts were examined with the aid of a stereo microscope at magnifications up to 50x.The implant was assumed to be for the right knee.The articulating surfaces of the insert had burnishing, scratching and third-body indentations.These are common damage modes of uhmwpe.Explantation damage was also observed on the insert.Mar concluded: "burnishing, scratching and third-body indentations were observed on the insert.These are common damage modes of uhmwpe.The proximal surface of the locking wire was observed to be pressed against the insert.The fracture surface of the wire is consistent with an overload condition.No material or manufacturing defects were observed on the surfaces examined." medical records received and evaluation: a review of the provided medical records by a consulting clinician concluded: "there is no clinical or past medical history, no patient demographics, and no primary or revision operative reports or clinical indications for the revision surgery available for review.The likely cause of the locking wire fracture was trauma to the insert at the time of surgical implantation.No material or manufacturing defects were observed on the explanted insert." device history review: device history review indicated the devices accepted into final stock from the reported lot were free from discrepancies.Complaint history review: there has been no other event for the lot referenced.Conclusions: the mar concluded that burnishing, scratching and third-body indentations were observed on the insert.The fracture surface of the wire is consistent with an overload condition.The medical review concluded that primary harm involved is locking wire fracture likely due to trauma at the time of surgical implantation.No material or manufacturing defects were observed on the explanted insert.No further investigation is possible at this time , if further information becomes available this investigation will be re-opened.

Event Description

A wire shaped meal foreign body in the lat.Dorsal knee was observed.No complaints from the patient.On (b)(6) 2017: it was reported that the patient has been revised.

• Brand Name: NO 6. TRIATHLON TS PLUS TIBIAL INSERT X3 POLY 16MM
• 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: 6210848
• MDR Text Key: 63703473
• Report Number: 0002249697-2016-04029
• Device Sequence Number: 1
• Product Code: MBH
• Combination Product (y/n): N
• PMA/PMN Number: K141056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 03/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2021
• Device Catalogue Number: 5537-G-616
• Device Lot Number: DR46EE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/29/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/22/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/13/2016
• 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): Other; Required Intervention
• Patient Age: 58 YR