MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH DURA DURATION A/P TIB SM 25; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, C

Catalog Number	6642-1-625
Medical Device Problem Code	Unstable (1667)
Health Effect - Clinical Codes	Injury (2348); Ambulation or Postural Difficulties (2544)
Date of Event	01/30/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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
As reported: "patient complains of stability issues".Patient's right knee was revised 21 years post implant.A duracon insert was swapped for a 25 ap lipped insert.Prior to primary implant, patient has a history of a "tib-fib fracture" as the result of a motor vehicle accident with comorbidities of degenerative ankle disease, morbid obesity, hypertension, and glaucoma.Rep provided x-rays, primary operative report, explant pictures, and vitals and reported that all information available to him has been submitted.
Event or Problem Description
As reported: "patient complains of stability issues".Patients right knee was revised 21 years post implant.A duracon insert was swapped for a 25 ap lipped insert.Prior to primary implant, patient has a history of a "tib-fib fracture" as the result of a motor vehicle accident with comorbidities of degenerative ankle disease, morbid obesity, hypertension, and glaucoma.Rep provided x-rays, primary operative report, explant pictures, and vitals and reported that all information available to him has been submitted.
Additional Manufacturer Narrative
An event regarding instability involving a duracon insert was reported.Instability was not confirmed but wear of the insert was confirmed by explant photos provided.Method & results: product evaluation and results: the reported device was not returned however photographs were provided for review.The photographs note the following: significant wear is noted on the posterior end of the tibial insert.Some biological material is shown on the device.The photos show nothing else of note.Medical records received and evaluation: a review of the provided medical information by a clinical consultant indicated: in this morbidly obese patient with a difficult post-malunited fracture reconstruction total knee arthroplasty, the survivorship of the components for over twenty-one years is excellent.Well-fixed and positioned components did not require revision, which was limited to a new ap lipped tibial insert.There is no evidence of any problems with implant design, manufacturing or materials related to this clinical situation.Product history review: not performed as the device lot details were not provided.Complaint history review: not performed as the device lot details were not provided.Conclusions: the exact cause of the event could not be determined however medical review did conclude the following: in this morbidly obese patient with a difficult post-malunited fracture reconstruction total knee arthroplasty, the survivorship of the components for over twenty-one years is excellent.Well-fixed and positioned components did not require revision, which was limited to a new ap lipped tibial insert.There is no evidence of any problems with implant design, manufacturing or materials related to this clinical situation.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.

• Brand Name: DURA DURATION A/P TIB SM 25
• Common Device Name: PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, C
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 8373754
• Report Number: 0002249697-2019-01208
• Device Sequence Number: 19279993
• Product Code: MBH
• UDI-Device Identifier: 04546540318138
• UDI-Public: 04546540318138
• Combination Product (Y/N): N
• Initial Reporter State: DE
• Initial Reporter Country: US
• PMA/510(K) Number: K032163
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 1997
• 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): 06/17/2019

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 Catalogue Number: 6642-1-625
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/30/2019
• Supplement Date Received by Manufacturer: 05/21/2019
• Initial Report FDA Received Date: 02/27/2019
• Supplement Report FDA Received Date: 06/17/2019
• 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: 67 YR
• Patient Weight: 115