MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON #4 CR INSERT 9MM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Model Number 5530-P-409

Device Problem Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Date 02/13/2016

Event Type  Injury  

Event Description

It has been reported by the healthcare facility that a patient has contacted them saying that their "implants were not right." the healthcare facility is asking if any of the implants was part of a recall.A competitor's bone cement was used in conjunction with stryker implants.

Manufacturer Narrative

It was noted that the device is not available for evaluation.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.Review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other similar events for the lot referenced.Catalog numbers and lot codes of other devices listed in this report: 5510f402 triathlon cr fem comp #4 r-cem; lot #: amh8k.5520-b-400 triathlon prim tib baseplate cemented; lot #: amn7h.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.Device not returned.

• Brand Name: TRIATHLON #4 CR INSERT 9MM
• 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-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer Contact: diana rogers ; 210 centennial avenue; centennial park, elstree; borehamwood WD6 3-SJ ; UK WD6 3SJ ; 2082386500
• MDR Report Key: 14564873
• MDR Text Key: 293074987
• Report Number: 0002249697-2022-00790
• Device Sequence Number: 1
• Product Code: MBH
• UDI-Device Identifier: 07613327041774
• UDI-Public: 07613327041774
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K141056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/01/2022

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: 12/31/2020
• Device Model Number: 5530-P-409
• Device Catalogue Number: 5530P409
• Device Lot Number: LEU192
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/10/2022
• Initial Date FDA Received: 06/01/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/18/2015
• 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): Other