MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH X3 TRIATHLON CS INS #8 11MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number	5531-G-811
Medical Device Problem Codes	Fracture (1260); Unstable (1667)
Health Effect - Clinical Codes	Failure of Implant (1924); Injury (2348)
Date of Event	01/31/2020
Type of Reportable Event	Serious Injury
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.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.
Event or Problem Description
It was reported that the patient was complaining of instability.When the patient was brought to the or and the knee was opened it was noted the ps post was broken off.
Additional Manufacturer Narrative
An event regarding instability and crack/fracture involving a triathlon insert was reported.The event of crack/fracture was confirmed.By inspection of returned device and the event of instability was not confirmed method & results: product evaluation and results.Visual inspection of the returned device noted the following: examination of the device returned indicated that it was returned fractured at the post.Backside impressions on the distal surface of insert are consistent with contact against a tibial base plate.Damage was observed on the articulating surface and anterior surface of the post which is consistent with contact against the femoral component.The damage present on the articulating surface is consistent with burnishing, scratching, and third body indentations; the fracture initiated on the anterior surface and propagated posteriorly.Macroscopic surface features indicate that the fracture is consistent with fatigue with final fracture occurring in overload.Material analysis of the returned device noted the following: the post fracture is consistent with a fatigue fracture with final fracture occurring in overload.The damage on the articulating surface of the insert was consistent with burnishing, scratching,and third body indentations; based on the given information, no identifiable materials or manufacturing discrepancies were observed on the surfaces examined.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: according to the material analysis report, it is likely the fracture of the device was caused by overload conditions.The exact cause of the overload conditions could not be determined because insufficient information was provided.It cannot be confirmed if the fracture of the device contributed to the instability described in the event.Further information such as pathology reports, 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.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
It was reported that the patient was complaining of instability.When the patient was brought to the or and the knee was opened it was noted the ps post was broken off.

• Brand Name: X3 TRIATHLON CS INS #8 11MM
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 9774415
• Report Number: 0002249697-2020-00421
• Device Sequence Number: 2573733
• Product Code: LPH
• UDI-Device Identifier: 07613327046083
• UDI-Public: 07613327046083
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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): 04/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2014
• Device Model Number: 5531-G-811
• Device Catalogue Number: 5531G811
• Device Lot Number: LBJ487
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/06/2020
• Initial Date Received by Manufacturer: 02/03/2020
• Supplement Date Received by Manufacturer: 03/18/2020
• Initial Report FDA Received Date: 03/02/2020
• Supplement Report FDA Received Date: 04/15/2020
• 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: Hospitalization; Required Intervention
• Patient Age: 64 YR