MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON PRIM CEM FXD BPLT #2; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, C

Catalog Number 5520B200

Device Problems Material Deformation (2976); Positioning Problem (3009)

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

Event Date 04/28/2010

Event Type  Injury  

Manufacturer Narrative

An event regarding a size/fit issue involving a triathlon baseplate 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: visual inspection of the returned device indicates explantation damage is visible but no other relevant pathological findings are evident.Bone cement with adequate trabecular bone imprint would suggest that component fixation was adequate.Examination of the devices with material analysis engineer indicated not related to material integrity issue.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 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 on and never got better.Patient stated that she had a revision done on or about (b)(6) 2011.Update from clinician indicated 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 PRIM CEM FXD BPLT #2
• 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: 7480550
• MDR Text Key: 107143408
• Report Number: 0002249697-2018-01320
• 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
• Report Date: 05/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/02/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2014
• Device Catalogue Number: 5520B200
• Device Lot Number: SNBSP
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/16/2018
• Date Manufacturer Received: 04/05/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/24/2009
• 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: 52 YR
• Patient Weight: 56