MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRI TS BASEPLATE SIZE 5; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number 5521-B-500

Device Problem Failure to Align (2522)

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

Event Date 03/26/2018

Event Type  malfunction  

Manufacturer Narrative

Review of the device history records indicate that devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.A supplemental report will be submitted upon completion of the investigation.

Event Description

Size #5 baseplate and augment didn't sit flush together.When augment used with a replacement baseplate (#5), augment and baseplate sat properly.

Manufacturer Narrative

An event regarding seating/locking issues involving a triathlon baseplate was reported.The event was not confirmed.Conclusions: the reported event is not confirmed.The returned device was found to be within specifications dimensionally and functionally.See attached inspection report.Discussion with marketing and product support engineering group assessed both devices and found the devices to be functionally acceptable.If additional information becomes available, this investigation will be reopened.

Event Description

Size #5 baseplate and augment didn't sit flush together.When augment used with a replacement baseplate (#5), augment and baseplate sat properly.

• Brand Name: TRI TS BASEPLATE SIZE 5
• 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: 7446861
• MDR Text Key: 106043981
• Report Number: 0002249697-2018-01186
• Device Sequence Number: 1
• Product Code: MBH
• UDI-Device Identifier: 07613327026320
• UDI-Public: 07613327026320
• 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: 08/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2023
• Device Catalogue Number: 5521-B-500
• Device Lot Number: BE79YA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/03/2018
• Date Manufacturer Received: 07/23/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 59 YR
• Patient Weight: 81