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

Catalog Number	5532-G-211
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/17/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If additional information is received, it will be provided in a supplemental report upon completion of the investigation.Not available.
Event or Problem Description
It was reported by the sales rep that during the operation, surgeon used insert impactor to push tibia insert into locking mechanism of tibia tray but the tibia insert could not be locked with the tibia tray ( tibia insert was not fit with the tibia tray).So surgeon decided to remove the tibia insert and a new tibia insert was used immediately.The case was completed successfully and no delay in the case.
Additional Manufacturer Narrative
An event regarding seating/locking issue involving a triathlon insert was reported.The event was confirmed based on the visual inspection of the returned device.Method & results: product evaluation and results: one insert with catalog number 5532-g-211 and lot code lfa837 was returned for evaluation within its unit carton.Damage is visible on the inferior anterior side of the insert.The locking wire of the insert is also bent.A review of the returned device by a material analysis engineer indicated: damage was observed on the insert consistent with attempted implantation and explantation.In-service use damages also observed.Based on the given information, no identifiable materials or manufacturing discrepancies were observed on the surfaces examined.Clinician review: no medical records were received for review with a clinical consultant.Product history review: indicated all devices were manufactured and accepted into final stock with no reported discrepancies complaint history review: there have been no other similar events for the lot referenced.Conclusion: one insert with catalog number 5532-g-211 and lot code lfa837 was returned for evaluation within its unit carton.Damage is visible on the inferior anterior side of the insert.The locking wire of the insert is also bent.A review of the returned device by a material analysis engineer indicated: damage was observed on the insert consistent with attempted implantation and explantation.In-service use damages also observed.Based on the given information, no identifiable materials or manufacturing discrepancies were observed on the surfaces examined.The exact cause of the event could not be determined because insufficient information was provided.Further information such as images of the device taken when the alleged event was identified and primary operative reports are required to complete the investigation for confirming the event and determining a root cause.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 or Problem Description
It was reported by the sales rep that during the operation, surgeon used insert impactor to push tibia insert into locking mechanism of tibia tray but the tibia insert could not be locked with the tibia tray ( tibia insert was not fit with the tibia tray).So surgeon decided to remove the tibia insert and a new tibia insert was used immediately.The case was completed successfully and no delay in the case.

• 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
• MDR Report Key: 8336174
• Report Number: 0002249697-2019-01034
• Device Sequence Number: 1357525
• Product Code: MBH
• UDI-Device Identifier: 07613327046212
• UDI-Public: 07613327046212
• Combination Product (Y/N): N
• Initial Reporter Country: TH
• PMA/510(K) Number: K141056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/23/2019

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: 05/31/2021
• Device Catalogue Number: 5532-G-211
• Device Lot Number: LFA837
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/15/2019
• Initial Date Received by Manufacturer: 01/17/2019
• Supplement Date Received by Manufacturer: 03/26/2019
• Initial Report FDA Received Date: 02/13/2019
• Supplement Report FDA Received Date: 04/23/2019
• 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