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

Catalog Number	5530-G-609
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/09/2019
Type of Reportable Event	Malfunction
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.Device not returned.
Event or Problem Description
Surgeon cemented cr triathlon femur and tibia into patient.Used a trial cr liner to cement with.Then inserted the real poly, but didn't engage the back of the liner before impacting it in.Poly was then not inserted correctly.Had to remove the poly, which ruined the wire and required us to open another poly cr insert.We had another poly, so patient was unaffected by this.Surgeon identified that the poly wasn't locked in at the back.Surgeon agreed this was a surgeon error.Item was thrown away as it was not known that it could/ should be returned until rep spoke to rm.
Additional Manufacturer Narrative
An event regarding seating/locking issue involving a triathlon insert was reported.The event was not confirmed.Method & results: product evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device was not returned.Medical records received and evaluation: no medical records were received for review with a clinical consultant.Product history review: a review of the device manufacturing records indicate that all devices accepted into final stock were free from discrepancies.Complaint history review: there have been no other similar events for the lot referenced.Conclusions: as reported the cr insert didn't engage the back of the liner before impacting it in.This was noticed during operation and it was removed and replaced with another poly cr insert.Surgeon identified that the poly wasn't locked in at the back.The event was not confirmed as insufficient information was provided.Per surgical protocol for the triathlon knee system, lspk42 rev.1, "the posterior lip of the tibial insert must fit beneath the lip on the posterior primary tibial baseplate wall." but the surgeon identified that the poly wasn't locked in at the back.Surgeon agreed this was a surgeon error.Thus, the alleged seating/locking issue was deemed caused by the surgeon, i.E.User error.No further investigation for this event is possible at this time as no devices and/ or insufficient information was received by stryker orthopaedics.If devices and / or additional information become available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
Surgeon cemented cr triathlon femur and tibia into patient.Used a trial cr liner to cement with.Then inserted the real poly, but didn't engage the back of the liner before impacting it in.Poly was then not inserted correctly.Had to remove the poly, which ruined the wire and required us to open another poly cr insert.We had another poly, so patient was unaffected by this.Surgeon identified that the poly wasn't locked in at the back.Surgeon agreed this was a surgeon error.Item was thrown away as it was not known that it could/ should be returned until rep spoke to rm.

• Brand Name: TRIATHLON CR 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
• MDR Report Key: 8588325
• Report Number: 0002249697-2019-01863
• Device Sequence Number: 19249247
• Product Code: MBH
• UDI-Device Identifier: 07613327050585
• UDI-Public: 07613327050585
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K141056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/25/2019

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: 01/31/2024
• Device Catalogue Number: 5530-G-609
• Device Lot Number: V74J9E
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/09/2019
• Supplement Date Received by Manufacturer: 05/30/2019
• Initial Report FDA Received Date: 05/07/2019
• Supplement Report FDA Received Date: 06/25/2019
• 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: 56 YR