MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRI TS BASEPLATE SIZE 6; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number 5521-B-600

Device Problems Failure To Adhere Or Bond (1031); Insufficient Information (3190)

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

Event Date 09/13/2016

Event Type  Injury  

Manufacturer Narrative

An evaluation of the device cannot be performed as the device was not returned to the manufacturer due to hospital policy.Additional information has been requested.Should additional information become available it will be reported in a supplemental report upon completion of the investigation.Not returned to the manufacturer.

Event Description

Tibia implant loose.

Manufacturer Narrative

An event regarding tibial component loosening involving a triathlon baseplate was reported.The event was not confirmed.Method & results: -device evaluation and results: not performed as the subject device was not returned for evaluation.-medical records received and evaluation: not performed as no medical records were provided.-device history review: device history review indicated the devices accepted into final stock from the reported lot were free from discrepancies.-complaint history review: chr review indicated that there were no other similar events reported for the subject manufacturing lot.Conclusions: an event regarding tibia component loosening involving a triathlon baseplate was reported.Neither the event could be confirmed nor the root cause of the event could be determined because insufficient information was provided.Further information such as device evaluation, x-rays, operative notes and patient details are required to further investigate this event to determine a root cause.No further investigation for this event is possible at this time.If additional information becomes available, this investigation will be reopened.

Event Description

Tibia implant loose.

• Brand Name: TRI TS BASEPLATE SIZE 6
• 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: 6013491
• MDR Text Key: 56922240
• Report Number: 0002249697-2016-03184
• 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: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/10/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2016
• Device Catalogue Number: 5521-B-600
• Device Lot Number: BRZP
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/20/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/11/2011
• 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): Required Intervention
• Patient Age: 57 YR