MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRI TS BASEPLATE SIZE 7; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number 5521-B-700

Device Problems Device Operates Differently Than Expected (2913); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/02/2017

Event Type  malfunction  

Manufacturer Narrative

A supplemental report will be submitted upon completion of the investigation.

Event Description

As reported: "opened implant for implantation.Went to take off preassembled cap (baby stem) to put on a 12x50mm cemented stem and could not turn off the plug.No adverse effects because we didn't implant." rep reported that procedure was right tka.Another implant (same cat #) was immediately available with no surgical delay.

Manufacturer Narrative

Additional information: product available to stryker and returned to manufacturer on; device evaluated by mfg.An event regarding disassembly issue involving a triathlon baseplate was reported.The event was not confirmed.Method & results: device evaluation and results: the device was returned in new condition.The end cap was locked in the baseplate.Packaging sme was able to remove the end cap using a manual torque wrench.The wrench showed that it took 40 inch/pound to release the end cap from the baseplate.This is within the 25-50 inch/pound tolerance as indicated in the drawing.The end cap was able to be screwed back in and removed with no issues.Medical records received and evaluation: not performed as medical records were not provided for review.Device history review: a device history review confirmed all devices accepted into finished goods conformed to specification.Complaint history review: no other events were reported for the lot indicated.Conclusions: the exact cause of the event could not be determined because the end cap was able to be removed using a torque wrench as indicated in the surgical protocol.The end cap was tightened to 30 inch/pound and was able to be removed by a packaging sme at 40 inch/pound which is within the drawing tolerance.No further investigation for this event is possible at this time.

Event Description

As reported: "opened implant for implantation.Went to take off preassembled cap (baby stem) to put on a 12x50mm cemented stem and could not turn off the plug.No adverse effects because we didn't implant." rep reported that procedure was right tka.Another implant (same cat #) was immediately available with no surgical delay.

• Brand Name: TRI TS BASEPLATE SIZE 7
• Type of Device: PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 7070107
• MDR Text Key: 93695647
• Report Number: 0002249697-2017-03444
• Device Sequence Number: 1
• Product Code: MBH
• UDI-Device Identifier: 07613327026351
• UDI-Public: 07613327026351
• 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
• Type of Report: Initial,Followup
• Report Date: 02/13/2018

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 Expiration Date: 07/06/2022
• Device Catalogue Number: 5521-B-700
• Device Lot Number: ARD7LA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2017
• Initial Date Manufacturer Received: 11/02/2017
• Initial Date FDA Received: 11/30/2017
• Supplement Dates Manufacturer Received: 01/15/2018
• Supplement Dates FDA Received: 02/13/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other