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

Model Number	5532-G-209
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	09/07/2011
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported by the patient, she had bilateral tka done on (b)(6) 2011.The patient stated she started to experience pain on both knees since her surgery.Patient stated its hard to get up and down from a chair.The patient stated her right knee is worse than the left.Patient's right knee was revised on (b)(6) 2013.The patient stated she is still experiencing pain on both knees and her pain hasn't gotten better.Patient is not able to climb steps without assistance.Patient would like to know if implants are of recall.
Additional Manufacturer Narrative
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.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.The following devices were also listed in this report: tri ts baseplate size 2; cat# 5521-b-200 ; lot# enpz.Triathlon ps fem comp #2r-cem; cat# 5515f202 ; lot# sylfa.Triathlon asymmetric x3 patella; cat# 5551-g-320 ; lot# yt8y.Triathlon fix.Peg 2 per pk; cat# 5575x000 ; lot# s4tkx.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.
Event or Problem Description
This mdr report is a duplicate.Please see h10 for details.It was reported by the patient, she had bilateral tka done on (b)(6), 2011.The patient stated she started to experience pain on both knees since her surgery.Patient stated its hard to get up and down from a chair.The patient stated her right knee is worse than the left.Patient's right knee was revised on (b)(6), 2013.The patient stated she is still experiencing pain on both knees and her pain hasn't gotten better.Patient is not able to climb steps without assistance.Patient would like to know if implants are of recall.
Additional Manufacturer Narrative
Mfr report # 0002249697-2022-00577 was found to be a duplicate of mfr report #0002249697-2013-02399.Any additional information for this event will be provided under mfr report #0002249697-2013-02399.

• Brand Name: TRIATHLON PS X3 TIBIAL INSERT
• Common Device Name: 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 ; EI NA
• Manufacturer Contact: joann ripoli ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 14186345
• Report Number: 0002249697-2022-00577
• Device Sequence Number: 5908665
• Product Code: MBH
• UDI-Device Identifier: 07613327046205
• UDI-Public: 07613327046205
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K141056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Device Explanted Year: 2013
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/02/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2015
• Device Model Number: 5532-G-209
• Device Catalogue Number: 5532-G-209
• Device Lot Number: LBY888
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/28/2022
• Supplement Date Received by Manufacturer: 08/22/2022
• Initial Report FDA Received Date: 04/22/2022
• Supplement Report FDA Received Date: 09/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/21/2010
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 58 YR
• Patient Sex: Female
• Patient Weight: 72 KG