MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON P/A CR BEADED #4R; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number	5517F402
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	Injury (2348)
Date of Event	07/17/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A review of the device history records indicate that devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.Device evaluated by mfr: device not available.
Event or Problem Description
The doctor revised a triathlon cr cementless femur due to bone collapse/implant subsidence.He revised to a ps femur with a 10mm distal augment and a ps insert.Update 18/july/2019 (b)(6): rep provided the primary tka operative report, pre-revision x-rays, and usage sheets from the primary and revision procedures and reported that no further information is available.
Additional Manufacturer Narrative
An event regarding subsidence involving a triathlon femoral component was reported.The event was confirmed by medical review.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: a review of the provided medical records by a clinical consultant stated the following comment: x-ray confirms subsidence of femur.Need revision operative reports, office/clinical reports, serial x-rays, etc.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: the exact cause of the event could not be determined because insufficient information was provided.Further information such as return of the device, revision operative reports, office/clinical reports, serial x-rays are needed to complete the investigation for determining root cause.No further investigation for this event is possible at this time.If devices and / or additional information become available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
The doctor revised a triathlon cr cementless femur due to bone collapse/implant subsidence.He revised to a ps femur with a 10mm distal augment and a ps insert.Update (b)(6) 2019 wg: rep provided the primary tka operative report, pre-revision x-rays, and usage sheets from the primary and revision procedures and reported that no further information is available.

• Brand Name: TRIATHLON P/A CR BEADED #4R
• 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: 8889024
• Report Number: 0002249697-2019-02827
• Device Sequence Number: 14169093
• Product Code: MBH
• UDI-Device Identifier: 07613327040944
• UDI-Public: 07613327040944
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: K141056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/10/2019

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: 11/30/2022
• Device Catalogue Number: 5517F402
• Device Lot Number: CPT9E
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/17/2019
• Supplement Date Received by Manufacturer: 09/13/2019
• Initial Report FDA Received Date: 08/13/2019
• Supplement Report FDA Received Date: 10/10/2019
• 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: Hospitalization; Required Intervention
• Patient Age: 69 YR