MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH X3 TRIATHLON CS INSERT #2 11MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number	5531-G-211
Medical Device Problem Code	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/09/2020
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.
Event or Problem Description
It was reported that during the surgical case, the doctor try to put the tibial bearing insert - cs size 2 (pn: 5531-g-211) into the patient's left knee but it was not fit suitably.So, the doctor decided to use another one, tibial bearing insert - cs size 2 (pn: 5531-g-211), but this one can be inserted into patient's left knee and the case was done completely.
Additional Manufacturer Narrative
An event regarding size/fit issue involving triathlon insert.The event was not confirmed.Method & results: product evaluation and results: visual inspection of images performed and stated that - damage and scratches can be seen on insert surface.Ma: material analysis is not performed as this is not related to material integrity.Damage consistent with explantation.Functional and dimensional not performed as product return in damage condition.Clinician review: no medical records were received for review with a clinical consultant.Product history review: review of the product history records indicate all devices were manufactured and accepted into final stock with no reported relevant discrepancies.Complaint history review: there have been no other similar events for the lot.Conclusion: it was reported that during surgical case, the doctor try to put the tibial insert cs size 2 into the patient left knee but it was no fit suitably.Visual inspection of images performed and stated that - damage and scratches can be seen on insert surface.Ma: material analysis is not performed as this is not related to material integrity.Damage consistent with explantation.Functional and dimensional not performed as product return in damage condition.The exact cause of the event could not be determined because no further information such as pre- and post-operative x-rays and the primary operative report as well as patient history and follow-up notes are needed to complete the investigation for determining root cause.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
It was reported that during the surgical case, the doctor try to put the tibial bearing insert - cs size 2 (pn: 5531-g-211) into the patient's left knee but it was not fit suitably.So, the doctor decided to use another one, tibial bearing insert - cs size 2 (pn: 5531-g-211), but this one can be inserted into patient's left knee and the case was done completely.Update: 10 minute surgical delay.

• Brand Name: X3 TRIATHLON CS INSERT #2 11MM
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 9676684
• Report Number: 0002249697-2020-00235
• Device Sequence Number: 2784343
• Product Code: JWH
• UDI-Device Identifier: 07613327045666
• UDI-Public: 07613327045666
• Combination Product (Y/N): N
• Initial Reporter Country: TH
• PMA/510(K) Number: K141056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/14/2020

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: 10/31/2023
• Device Model Number: 5531-G-211
• Device Catalogue Number: 5531G211
• Device Lot Number: LHS553
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2020
• Initial Date Received by Manufacturer: 01/09/2020
• Supplement Date Received by Manufacturer: 03/17/2020
• Initial Report FDA Received Date: 02/06/2020
• Supplement Report FDA Received Date: 04/14/2020
• 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: 78 YR