MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRI TS FEMUR SZ7 LEFT; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number	5512-F-701
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Neurological Deficit/Dysfunction (1982); Injury (2348); Joint Dislocation (2374); Ambulation or Postural Difficulties (2544)
Date of Event	08/30/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An event regarding revision due to dislocation involving a triathlon femoral component was reported.The event was confirmed through clinician review of the medical records provided.Method & results: product evaluation and results: no product was returned for evaluation however photographs were provided showing the explanted products.One photograph shows a recently explanted blood stained femoral component.It appears that the stem is attached to the femoral component.There is bone cement and tissue visible on the underside/internal fixation side of the femoral component.Clinician review: neurological disease of the patient with muscular insufficiency in combination with choice for ts components during the previous revision that did not address all contributing elements of the knee instability has caused a full knee dislocation within a week of the previous revision surgery to require another revision with conversion of the arthroplasty to a hinged mrh device.Product history review: not performed as no lot information was provided.Complaint history review: not performed as no lot information was provided.Conclusion: an event regarding revision due to dislocation was reported.The medical review indicated: neurological disease of the patient with muscular insufficiency in combination with choice for ts components during the previous revision that did not address all contributing elements of the knee instability has caused a full knee dislocation within a week of the previous revision surgery to require another revision with conversion of the arthroplasty to a hinged mrh device no further investigation is required 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 patient's left knee was revised due to dislocation (femoral component was sitting anterior to tibia).Surgeon reported dislocation was due to patient's neurological condition which limits ambulation to crawling around, and that there are no allegations against any stryker devices.Patient was revised to an mrh knee.

• Brand Name: TRI TS FEMUR SZ7 LEFT
• 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: 7916053
• Report Number: 0002249697-2018-03111
• Device Sequence Number: 11347475
• Product Code: MBH
• UDI-Device Identifier: 07613327026641
• UDI-Public: 07613327026641
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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: 2018
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/27/2018

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 Catalogue Number: 5512-F-701
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/30/2018
• Initial Report FDA Received Date: 09/27/2018
• 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: 70 YR