MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON PKR INSERT X3 #4 RM/LL -9MM; PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number 5630-G-429

Device Problems Detachment Of Device Component (1104); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Failure of Implant (1924); Pain (1994); Ambulation Difficulties (2544)

Event Date 05/08/2017

Event Type  Injury  

Manufacturer Narrative

It was noted that the device is not available for evaluation.Additional information has been requested and if received, will be provided in the supplemental report upon completion of the investigation.Not available.

Event Description

Patient called regarding implant has failed per surgeon according to xrays.Device is coming off the tibia not the femur.Patient is experiencing mobility issues, instability, pain, fear of falling, using a walker, curvature of her leg, rehab.Patient is dependent upon others for assistance.Was told another surgery is needed and is scared due to current issues.

Manufacturer Narrative

An event regarding tibial subsidence involving a triathlon insert was reported.Conclusions: the provided medical assessment indicated the subsidence of the anterior tibial baseplate.The insert is an integral part of the tibial component construct and will have to be explanted together with the subsided baseplate.Based on the provided information, there is no indication or allegation that the insert contributed to the event.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 regarding implant has failed per surgeon according to xrays.Device is coming off the tibia not the femur.Patient is experiencing mobility issues, instability, pain, fear of falling, using a walker, curvature of her leg, rehab.Patient is dependent upon others for assistance.Was told another surgery is needed and is scared due to current issues.

• Brand Name: TRIATHLON PKR INSERT X3 #4 RM/LL -9MM
• Type of Device: PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
• 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: cindy chuhinko ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6607589
• MDR Text Key: 76509307
• Report Number: 0002249697-2017-01757
• Device Sequence Number: 1
• Product Code: HRY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K082567
• 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: 08/18/2017

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: 05/16/2015
• Device Catalogue Number: 5630-G-429
• Device Lot Number: MJH7J3
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/08/2017
• Initial Date FDA Received: 06/02/2017
• Supplement Dates Manufacturer Received: 07/26/2017
• Supplement Dates FDA Received: 08/18/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/16/2010
• 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): Other
• Patient Age: 75 YR
• Patient Weight: 78