MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON CR X3 TIBIAL INSERT; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number 5530-G-213

Device Problems Material Deformation (2976); Scratched Material (3020); Insufficient Information (3190)

Patient Problems Pain (1994); Swelling (2091); Injury (2348)

Event Date 04/28/2010

Event Type  Injury  

Manufacturer Narrative

Review of the device history records indicate that devices were manufactured and accepted into final stock on with no relevant reported discrepancies.There have been no other events for the reported lot.A supplemental report will be submitted upon completion of the investigation.The following devices were also listed in this report: triathlon cr fem comp #3 l-cem; cat#5510f301; lot# srrty, triathlon asymmetric x3 patella; cat35551-g-299; lot# 00e5, triathlon prim cem fxd bplt #2; cat#5520b200; lot# snbsp.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.

Event Description

Patient called and stated that she had a left tka on (b)(6) 2010.Patient stated that she experienced pain, swelling and stiffness since day one and never got better.Patient stated that she had a revision done on or about (b)(6) 2011.

Manufacturer Narrative

The following devices were also listed in this report: triathlon asymmetric x3 patella; cat# 5551-g-299; lot# 00e5.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.Additional information: an event regarding rom involving was reported.The event was confirmed through review of the provided medical records and x-rays by a clinical consultant.Method & results: -device evaluation and results: burnishing, scratching and third body indentations were observed on the insert.These are common damage modes of uhmwpe.Explantation damage also observed.Based on the given information, no identifiable materials or manufacturing discrepancies were observed on the surfaces examined.-medical records received and evaluation: a review of the provided medical records and x-rays by a clinical consultant indicated: inadequate bone resection on the femoral side in combination with femoral component rotatory malposition, tibial baseplate posterior overhang, oblique patellar bone resection and choice for a relatively thick tibial bearing during primary arthroplasty have contributed to knee joint lengthening with stiffness of the knee and major functional impairment requiring revision.-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 investigation concluded that inadequate bone resection on the femoral side in combination with femoral component rotatory malposition, tibial baseplate posterior overhang, oblique patellar bone resection and choice for a relatively thick tibial bearing during primary arthroplasty have contributed to knee joint lengthening with stiffness of the knee and major functional impairment requiring revision.It was reported that patient is also inquiring if her implants are part of a recall.As per product recall verification response, it is confirmed that the reported device is not subject to a recall.No further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.

Event Description

Patient called and stated that she had a left tka on (b)(6) 2010.Patient stated that she experienced pain, swelling and stiffness since day one and never got better.Patient stated that she had a revision done on or about (b)(6) 2011.Update from clinician: inadequate bone resection on the femoral side, femoral component rotatory malposition, tibial baseplate posterior overhang, oblique patellar bone resection, choice for a relatively thick tibial bearing.

• Brand Name: TRIATHLON CR X3 TIBIAL INSERT
• 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: 7309203
• MDR Text Key: 101361204
• Report Number: 0002249697-2018-00601
• Device Sequence Number: 1
• Product Code: MBH
• Combination Product (y/n): N
• PMA/PMN Number: K141056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 05/09/2018

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: 06/30/2013
• Device Catalogue Number: 5530-G-213
• Device Lot Number: LBD650
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/16/2018
• Initial Date Manufacturer Received: 02/05/2018
• Initial Date FDA Received: 03/02/2018
• Supplement Dates Manufacturer Received: 04/12/2018
• Supplement Dates FDA Received: 05/09/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 52 YR
• Patient Weight: 56