MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON PRIM CEM FXD BPLT #2; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Model Number	5520-B-200
Medical Device Problem Codes	Unstable (1667); Migration (4003)
Health Effect - Clinical Code	Ambulation or Postural Difficulties (2544)
Date of Event	08/09/2016
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 has been similar events for the lot referenced however, it is related to the same patient.An evaluation of the device cannot be performed as the device was not returned to the manufacturer.Should additional information become available it will be reported in a supplemental report upon completion of the investigation.
Event or Problem Description
This pr was raised from a medical review for another event.The patient had left knee arthroplasty on (b)(6) 2011.A quad repair was carried out six months post implantation.Revision surgery took place on (b)(6) 2012 due to instability whereby the insert was revised.Revision surgery took place on (b)(6) 2016 due to subsidence and instability whereby all components were revised.
Additional Manufacturer Narrative
Reported event: an event regarding subsidence and instability involving a triathlon baseplate 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.-clinician review: a review of the provided medical information by a clinical consultant indicated: {.} on (b)(6), 2016 she presented with left knee pain.And the record states that she was taken to the operating room on that day for revision of her left knee due to complications of orthopedic hardware.The operation note of (b)(6), 2016 is reviewed.The postoperative diagnosis was "left knee complications of orthopedic hardware from previous total knee arthroplasty".Surgery was performed by dr.The patient was revised using depew tc three revision components the indications state that there was evidence of subsidence of the base plate and also signs of mid-flexion instability.The operation report itself does not report any loosening of the patella femoral component or tibial component.{.} i can confirm that the events occurred since i was able to review the operation reports and i reviewed preop and post op x-rays.Regarding the possible root cause of this event, i cannot determine this for certain.I see no abnormality with the implant itself.-product history review: review of the device history records indicate the devices were manufactured and accepted into final stock with no relevant reported discrepancies.-complaint history review: there have been 2 other similar events for the lot referenced.Conclusions: a review of the provided medical information by a clinical consultant indicated: i can confirm that the events occurred since i was able to review the operation reports and i reviewed pre op and post op x-rays.Regarding the possible root cause of this event, i cannot determine this for certain.I see no abnormality with the implant itself.The exact cause of the event could not be determined because insufficient information was provided.Further information such as return of the device, 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 devices and / or additional information become available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
This pr was raised from a medical review for another event.The patient had left knee arthroplasty on (b)(6) 2011.A quad repair was carried out six months post implantation.Revision surgery took place on (b)(6) 2012 due to instability whereby the insert was revised.Revision surgery took place on (b)(6) 2016 due to subsidence and instability whereby all components were revised.

• Brand Name: TRIATHLON PRIM CEM FXD BPLT #2
• 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: 12496842
• Report Number: 0002249697-2021-01574
• Device Sequence Number: 14430245
• Product Code: MBH
• UDI-Device Identifier: 07613327041569
• UDI-Public: 07613327041569
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K141056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/20/2021

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: 04/30/2016
• Device Model Number: 5520-B-200
• Device Catalogue Number: 5520B200
• Device Lot Number: S4A3M
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/27/2021
• Supplement Date Received by Manufacturer: 09/23/2021
• Initial Report FDA Received Date: 09/20/2021
• Supplement Report FDA Received Date: 10/20/2021
• 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: 57 YR