MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON PRIM TIB BASEPLATE - CEMENTED; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number 5520-B-300

Device Problems Failure to Osseointegrate (1863); Malposition of Device (2616); Insufficient Information (3190)

Patient Problems Rheumatoid Arthritis (1724); Pain (1994); Inadequate Osseointegration (2646); Osteopenia/ Osteoporosis (2651); Limited Mobility Of The Implanted Joint (2671)

Event Date 12/16/2015

Event Type  Injury  

Manufacturer Narrative

An evaluation of the device cannot be performed as the device was not returned to the manufacturer.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

Patient had a knee revison on her left leg on (b)(6) 2015 after experiencing pain and loss of mobility for approximately 11 months.Patient had a bone scan done with revealed that the component was loose.Original implant date was (b)(6) 2014.

Manufacturer Narrative

Reported event: an event regarding loosening involving a triathlon baseplate was reported.The event was confirmed.Method & results: device evaluation and results: a visual, functional and dimensional inspection could not be performed as the device was not returned.Medical records received and evaluation: the provided medical records were reviewed by a consulting clinician who indicated: "the primary harm involved is aseptic loosening of the tibial component of a primary tka in a patient with rheumatoid arthritis and osteopenia.The component itself appeared to be implanted in a sub optimal varus position.The combination of poor bone stock and mechanical overload contributed to early loosening of this component.There is no evidence for any defect in the implant or its manufacture." device history review: device history review indicated the devices accepted into final stock from the reported lot were free from discrepancies complaint history review: there has been no other event for the lot referenced.Conclusions: the reported event was confirmed as per provided medical records that were reviewed by consulting clinician who indicated that primary harm involved is aseptic loosening of the tibial component in a patient with rheumatoid arthritis and osteopenia.The component itself appeared to be implanted in a sub optimal varus position.The root cause of the primary harm determined is the combination of poor bone stock and mechanical overload which resulted in early loosening of the component.There is no evidence for any defect in the implant or its manufacture.A capa trend analysis was conducted for the reported failure mode and concluded that loosening may result from other factors not necessarily related to the device.If additional information and/or device becomes available, this investigation will be reopened.Product surveillance will continue to monitor for trends.

Event Description

Patient had a knee revison on her left leg on (b)(6) 2015 after experiencing pain and loss of mobility for approximately 11 months.Patient had a bone scan done with revealed that the component was loose.Original implant date was (b)(6) 2014.

• Brand Name: TRIATHLON PRIM TIB BASEPLATE - CEMENTED
• 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: jadwiga degrado ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 5631967
• MDR Text Key: 44414892
• Report Number: 0002249697-2016-01519
• 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: consumer,other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2019
• Device Catalogue Number: 5520-B-300
• Device Lot Number: KGKID
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/30/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/29/2014
• 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: 65 YR
• Patient Weight: 86