MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRI TS BASEPLATE SIZE 4 PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number 5521-B-400

Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problem Injury (2348)

Event Date 11/20/2018

Event Type  Injury  

Manufacturer Narrative

Reported event: an event regarding tibial loosening involving a triathlon ts baseplate component was reported. The event was not confirmed. Method & results: device evaluation and results: not performed as product was not returned. Medical records received and evaluation: no medical records were received for review with a clinical consultant. Device history review: all devices were manufactured and accepted into final stock with no relevant reported discrepancies. Complaint history review: there have been no other similar events for the reported lot. Conclusion: the exact cause of the event could not be determined because insufficient information was provided. Additional information, including operative reports, progress notes, x-rays and return of the device are needed to fully investigate the event. If further information becomes available or the product is returned, this investigation will be re-opened.

Event Description

It was reported through the submission of a primary and a revision implant sheet, that the patient's right knee was revised. Comparing the sheets, a 4x11 cs insert and size 4 universal tibial baseplate were revised to a 4x19 cs insert, another size 4 universal tibial baseplate with a 12x100 cemented stem and 4x5 tibial augment. It was later reported that the patient's grandson jumped on patient's knee which caused loosening of the tibial component. The tibial component and liner were revised as originally reported.

• Brand Name: TRI TS BASEPLATE SIZE 4
• 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: anna smith ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 8174007
• MDR Text Key: 130654500
• Report Number: 0002249697-2018-04060
• 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

Reporter Occupation

• Type of Report: Initial
• Report Date: 12/18/2018

1 Device Was Involved in the Event

1 Patient Was Involved in the Event

• Date FDA Received: 12/18/2018
• Is This An Adverse Event Report?: Yes
• Is This A Product Problem Report?: No
• Device Operator: HEALTH PROFESSIONAL
• Device Catalogue Number: 5521-B-400
• Device LOT Number: VS3AA
• Was Device Available For Evaluation?: No
• Is The Reporter A Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 11/20/2018
• Was Device Evaluated By Manufacturer?: Device Not Returned To Manufacturer
• Date Device Manufactured: 08/04/2016
• Is The Device Single Use?: Yes
• Is this a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient TREATMENT DATA

Date Received: 12/18/2018 Patient Sequence Number: 1