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-513
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/29/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Review of the product history records indicate devices were manufactured and accepted into final stock with no relevant 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.Device not returned.
Event or Problem Description
Liner would not lock.Update (b)(6) 2018: reporter indicated "yes" to surgical delay.
Additional Manufacturer Narrative
Reported event: an event regarding seating/locking issues involving a triathlon insert was reported.The event was confirmed through evaluation of the returned device.Method & results: -device evaluation and results: a review was completed by the materials engineer who concluded: damage observed on the insert consistent with attempted implantation and contact against a hard object.Based on the given information, no identifiable materials or manufacturing discrepancies were observed on the surfaces examined.-medical records received and evaluation: a medical review was not performed because no medical information was provided.-device history review: review indicated all devices were manufactured and accepted into final stock with no reported discrepancies.-complaint history review: review indicated there have been no other similar events for the reported lot.Conclusions: the insert component was returned for review - a review was completed by the materials engineer who concluded: damage observed on the insert consistent with attempted implantation and contact against a hard object.Based on the given information, no identifiable materials or manufacturing discrepancies were observed on the surfaces examined.While it can be confirmed that a seating issue did take place through return of the component, the root cause cannot be determined as insufficient information was provided.Further information such as operative reports/images of the device taken when the alleged event was identified is required to complete the investigation.
Event or Problem Description
Liner would not lock.Update 05/december/2018: reporter indicated "yes" to surgical delay.

• 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: 8203751
• Report Number: 0002249697-2018-04158
• Device Sequence Number: 1670390
• Product Code: MBH
• UDI-Device Identifier: 07613327050790
• UDI-Public: 07613327050790
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K141056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/11/2019

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: 05/31/2023
• Device Catalogue Number: 5532-G-513
• Device Lot Number: 88602018D
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/09/2019
• Initial Date Received by Manufacturer: 11/29/2018
• Supplement Date Received by Manufacturer: 01/11/2019
• Initial Report FDA Received Date: 12/28/2018
• Supplement Report FDA Received Date: 02/11/2019
• 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: 52 YR
• Patient Weight: 92