MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRITANIUM BPLATE TRIATHLON S3; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, C

Catalog Number 5536B300

Device Problems Osseointegration Problem (3003); Scratched Material (3020)

Patient Problems Pain (1994); Injury (2348); Inadequate Osseointegration (2646)

Event Date 06/28/2017

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Surgeon implanted a right tritanium tibia on (b)(6) 2016.According to the surgeon: the patient's initial radiographs were uneventful.The patient began experiencing increased pain and subsequent imaging reveled what appeared to be a tibial component that failed to integrate.He performed a revision of the tibial component from a tritanium tibial component to a universal baseplate.

Manufacturer Narrative

An event regarding pain and tibial loosening involving a tritanium baseplate was reported.The event was confirmed through medical review.Method & results: -device evaluation and results: the baseplate and insert without its locking wire were returned for analysis.Explantation damage is visible on the baseplate.There is some adherent bone on the baseplate.Explantation damage is visible on the insert.-medical records received and evaluation: the current case concerns loosening of a tritanium baseplate with radiolucent line development and migration in varus and posterior tilt deformity becoming evident at a little over 1-year post arthroplasty.Otherwise components had adequate size and position of the baseplate with correct alignment of the knee early post arthroplasty.The fact that baseplate loosening required revision already within 15-months proves that failure was caused by lack of primary bone ingrowth fixation, not secondary failure of a well-ingrown device.There is a minimal amount of bone present on the explanted material but quite likely fibrous tissue is present between this bone layer and the actual implant surface.The radiographic amount of loosening is such that these findings would not be compatible with any relevant area of bone ingrowth fixation.Only histopathology of the device could detail this but would not change any conclusion about the established loosening of the tritanium baseplate.From the patient-related perspective, there is the patient obesity with a bmi of 37 where 25 represents the upper limit of normal.Excessive weight is not normally a root cause for device failure although it may increase the effects of overload conditions from other causes.Given the relatively severe degree of overweight this has played quite likely a relevant role although still a secondary one.-device history review: indicated all devices were manufactured and accepted into final stock with no reported discrepancies.-complaint history review: there have been no other similar events for the lot referenced.Conclusions: the medical review indicates: an unknown combination of procedure-related and/or patient-related factors has contributed to a relative overload condition on the baseplate causing disruption of the implant-bone interface with consequent loosening of a non-ha/pa-coated implant bone interface that has lower resistance to such overload conditions.The exact cause of the event could not be determined based on the information provided further information such as operative reports as well as patient history and follow up notes are needed to complete the investigation for determining a root cause.A capa trend analysis was conducted for the reported failure mode and concluded tritanium baseplate loosening may result from factors not related to the device.No further investigation for this event is possible at this time as insufficient information was received by stryker orthopaedics.If additional information becomes available, this investigation will be reopened.

Event Description

Surgeon implanted a right tritanium tibia on (b)(6) 2016.According to the surgeon: the patient's initial radiographs were uneventful.The patient began experiencing increased pain and subsequent imaging reveled what appeared to be a tibial component that failed to integrate.He performed a revision of the tibial component from a tritanium tibial component to a universal baseplate.

• Brand Name: TRITANIUM BPLATE TRIATHLON S3
• Type of Device: PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, C
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-LIMERICK; raheen business park; limerick NA
• Manufacturer Contact: brian lauro ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6745924
• MDR Text Key: 81111386
• Report Number: 0002249697-2017-02290
• 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,other
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/18/2020
• Device Catalogue Number: 5536B300
• Device Lot Number: CTD8342
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/12/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/28/2017
• Initial Date FDA Received: 07/26/2017
• Supplement Dates Manufacturer Received: 08/18/2017
• Supplement Dates FDA Received: 09/14/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/18/2015
• 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): Hospitalization; Required Intervention
• Patient Age: 67 YR
• Patient Weight: 108