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

Catalog Number	5532-G-209
Medical Device Problem Code	Noise, Audible (3273)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/01/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The following devices were also listed in this report: triathlon ps fem comp #2r-cem; cat# 5515f202; lot# btd2e.Tri ts baseplate size 2; cat# 5521-b-200; lot# abs3aa.Triathlon symmetric x3 patella; cat# 5550-g-339; lot# hy7p.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.Review of the device history records indicate devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other 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.
Event or Problem Description
Patient reported that her triathlon knee implant have a clunking sensation while walking.Patient is nine weeks post surgery.Patient stated that her knee feels great, but she does notice a clunking sensation when she walks.
Event or Problem Description
Patient reported that her triathlon knee implant have a clunking sensation while walking.Patient is nine weeks post surgery.Patient stated that her knee feels great, but she does notice a clunking sensation when she walks.
Additional Manufacturer Narrative
An event regarding an audible noise involving a triathlon insert was reported.The event was not confirmed.Method & results: device evaluation and results: not performed as no product was returned.It remains implanted.Medical records received and evaluation: the medical review indicated: there is no follow-up subsequent to october 23, 2017 and no confirmation of ¿clunking sensation¿ or description of findings on physical examination.The two likely causes of a post-operative total knee arthroplasty clunking are either related to the ps tibial insert post or the patella subluxation.Both of these may resolve with restoration of muscle strength around the knee.There is no evidence that factors of faulty component design, manufacturing or materials are responsible for this clinical situation.Device history review: indicate 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 lot referenced.Conclusion: the medical review indicated: there is no follow-up subsequent to october 23, 2017 and no confirmation of ¿clunking sensation¿ or description of findings on physical examination.The two likely causes of a post-operative total knee arthroplasty clunking are either related to the ps tibial insert post or the patella subluxation.Both of these may resolve with restoration of muscle strength around the knee.There is no evidence that factors of faulty component design, manufacturing or materials are responsible for this clinical situation.No further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.

• Brand Name: TRIATHLON PS X3 TIBIAL INSERT
• Common Device Name: PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, C
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 7129202
• Report Number: 0002249697-2017-03617
• Device Sequence Number: 11212346
• Product Code: MBH
• UDI-Device Identifier: 07613327046205
• UDI-Public: 07613327046205
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K141056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/17/2017
• Device Catalogue Number: 5532-G-209
• Device Lot Number: D72DWH
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/20/2017
• Supplement Date Received by Manufacturer: 01/23/2018
• Initial Report FDA Received Date: 12/19/2017
• Supplement Report FDA Received Date: 02/21/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 67 YR
• Patient Weight: 62