MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH #2 UNIVERSAL TIBIAL TEMPLATE; PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number 6541-2-602

Device Problem Mechanical Problem (1384)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/27/2018

Event Type  malfunction  

Manufacturer Narrative

It was noted that the device is not available for evaluation.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.

Event Description

During triathlon's ts implanting operation, we measured the offset after tibia size determination (# 2).The offset is determined at 6 o'clock in 11 o'clock direction.Tried to fix the tibial template with a pin and pull out the trial of the stem and it interfered with the tibial template and it did not escape.In the manual also # 1 to # 3 the offset was written up to 6 mm and confirmed with the staff on the spot, but still interfered.Since it can not be helped, i marked the final position of the tibial template, punctured the pin of the tibial template that positioned with great difficulty, pulled out the stem trial first and proceeded to the next step.After the operation i got instruments and got an offset of 6 mm against the # 2 tibial template and i could not get out of the stem trial.It is a situation where it gets out while interfering with # 3.

Event Description

During triathlon's ts implanting operation, we measured the offset after tibia size determination (# 2).The offset is determined at 6 o'clock in 11 o'clock direction.Tried to fix the tibial template with a pin and pull out the trial of the stem and it interfered with the tibial template and it did not escape.In the manual also # 1 to # 3 the offset was written up to 6 mm and confirmed with the staff on the spot, but still interfered.Since it can not be helped, i marked the final position of the tibial template, punctured the pin of the tibial template that positioned with great difficulty, pulled out the stem trial first and proceeded to the next step.After the operation i got instruments and got an offset of 6 mm against the # 2 tibial template and i could not get out of the stem trial.It is a situation where it gets out while interfering with # 3.

Manufacturer Narrative

An event regarding a size/fit issue involving a universal tibial template was reported.The event was not confirmed.Conclusion: the event could not be confirmed as the product was not returned and product inspection could not be performed.The exact cause of the event could not be determined because insufficient information was provided.No further investigation is possible at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.

• Brand Name: #2 UNIVERSAL TIBIAL TEMPLATE
• Type of Device: PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 7292771
• MDR Text Key: 100934884
• Report Number: 0002249697-2018-00537
• Device Sequence Number: 1
• Product Code: HRY
• Combination Product (y/n): N
• PMA/PMN Number: K172326
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Type of Report: Initial,Followup
• Report Date: 05/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 6541-2-602
• Device Lot Number: N2W01
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/27/2018
• Initial Date FDA Received: 02/23/2018
• Supplement Dates Manufacturer Received: 04/24/2018
• Supplement Dates FDA Received: 05/18/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other