MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON MB PATELLA PA A35; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number 5554L350

Device Problem Insufficient Information (3190)

Patient Problems Pain (1994); Loss of Range of Motion (2032); Scar Tissue (2060); Injury (2348)

Event Date 03/20/2017

Event Type  Injury  

Manufacturer Narrative

It was noted that the device is not available for evaluation.Additional information has been requested.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.

Event Description

Sales rep reported patient is less than 1 year post op, exact date of right knee primary implant (b)(6) 2016.She has only been able to flex 70 degrees and is in considerable pain.The surgeon had decided to debride scar tissue intensively.Surgeon measured thickness of patella in situ and observed a 31 mm thickness, patella was removed and thinned to 14 mm, replaced with a 29 symmetric patella.The 4x9 poly was replaced.Nothing was loose or broken.

Manufacturer Narrative

An event regarding arthrofibrosis involving a triathlon patella was reported.The event was not confirmed.Method & results: device evaluation and results: not performed as no device was returned for evaluation.Medical records received and evaluation: a review of the provided x-rays by a clinical consultant indicated: the indication for revision was provided as pain and stiffness with a limited range of motion (rom) of only 70° of flexion.Arthrofibrosis is the usual term used for this problem and literally indicates scar tissue formation in the joint.Range of motion (rom) of the knee was reported as 0° to 70° of flexion prior to revision which indeed is insufficient for routine daily activities.A knee flexion of 120° is usually considered adequate.Combining all facts and findings discussed, principal failure mode of this case is procedure-related as caused by arthrofibrosis of the arthroplasty post surgery probably also contributed by increased tension in the patello-femoral joint due to suboptimal bone resection of the patella during primary arthroplasty leaving an oversized pf-joint.The bearing was exchanged in combination with extensive debridement and scar tissue removal plus implantation of a smaller patellar component on a thinner patella.No other problems with the arthroplasty were observed.¿nothing was loose or fractured¿.Device history review: not performed as no lot information was provided.Complaint history review: not performed as no lot information was provided.Conclusions: the medical review indicates: total knee arthroplasty requiring extensile exposure has resulted in arthrofibrosis with impairment of knee functionality further contributed by increased tension in the patello femoral joint due to suboptimal bone resection of the patella during primary arthroplasty.An extensive scar tissue release was performed in combination with implantation of a smaller patella and liner exchange as required for adequate exposure.A capa trend analysis was conducted for the reported failure mode and concluded arthrofibrosis may result from other factors not necessarily related to the device.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

Sales rep reported patient is less than 1 year post op, exact date of right knee primary implant (b)(6) 2016.She has only been able to flex 70 degrees and is in considerable pain.The surgeon had decided to debride scar tissue intensively.Surgeon measured thickness of patella in situ and observed a 31mm thickness, patella was removed and thinned to 14mm, replaced with a 29 symetric patella.The 4x9 poly was replaced.Nothing was loose or broken.

• Brand Name: TRIATHLON MB PATELLA PA A35
• 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-LIMERICK; raheen business park; limerick NA
• Manufacturer Contact: cindy chuhinko ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6490672
• MDR Text Key: 72730979
• Report Number: 0002249697-2017-01261
• 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: 06/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 5554L350
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/25/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 75 YR
• Patient Weight: 74