MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRI RM/LL TIB AUG SZ2 10MM; KNEE JOINT PATELLOFEMOROTIBIAL METAL/POLYMER POROUS-COATED UNCEMENTED PROSTHESIS

Catalog Number	5546-A-202
Medical Device Problem Code	Osseointegration Problem (3003)
Health Effect - Clinical Codes	Injury (2348); Inadequate Osseointegration (2646)
Date of Event	02/07/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If additional information is received, it will be provided in a supplemental report upon completion of the investigation.Not returned.
Event or Problem Description
This pi is for a second revision surgery the patient underwent on 07 feb 2017 due to baseplate/tibial stem loosening.Excerpt from medical review: "loosening of the triathlon baseplate with associated stem extender was confirmed while femoral and patellar components proved to be well fixed and were as such retained." ¿the use of a relatively short 50-mm stem extender below an augment in a proximal tibial bone defect condition did not provide adequate stability to the newly implanted baseplate during the previous revision with excessive micromotion in the implant-bone interface resulting in early loosening requiring a second revision within short interval.".
Additional Manufacturer Narrative
An event regarding loosening involving a triathlon tibial augment was reported and confirmed through a medical review for this patient.Method & results: device evaluation and results: not performed as product was not returned clinician review: a review of the provided medical records by a clinical consultant indicated: the use of a relatively short 50-mm stem extender below an augment in a proximal tibial bone defect condition did not provide adequate stability to the newly implanted baseplate during the previous revision with excessive micromotion in the implant bone interface resulting in early loosening requiring a second revision within short interval.Clinical suspicion for presence of a lowgrade infection in the implant-bone interface, although notexplicitly proven, may have accelerated the baseplate fixation failure.Excess bone removal as required for removal of well-fixed cemented pkr baseplate during the first revision of sep 2016.Device history review: could not be performed as lot code information was not provided.Complaint history review: could not be performed as lot code information was not provided.Conclusion: a review of the provided medical records by a clinical consultant indicated: the use of a relatively short 50-mm stem extender below an augment in a proximal tibial bone defect condition did not provide adequate stability to the newly implanted baseplate during the previous revision with excessive micromotion in the implant bone interface resulting in early loosening requiring a second revision within short interval.Clinical suspicion for presence of a lowgrade infection in the implant-bone interface, although notexplicitly proven, may have accelerated the baseplate fixation failure.Excess bone removal as required for removal of well-fixed cemented pkr baseplate during the first revision of (b)(6) 2016.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
This pi is for a second revision surgery the patient underwent on (b)(6) 2017 due to baseplate/tibial stem loosening.Excerpt from medical review: "loosening of the triathlon baseplate with associated stem extender was confirmed while femoral and patellar components proved to be well fixed and were as such retained.".¿the use of a relatively short 50-mm stem extender below an augment in a proximal tibial bone defect condition did not provide adequate stability to the newly implanted baseplate during the previous revision with excessive micromotion in the implant-bone interface resulting in early loosening requiring a second revision within short interval.".

• Brand Name: TRI RM/LL TIB AUG SZ2 10MM
• Common Device Name: KNEE JOINT PATELLOFEMOROTIBIAL METAL/POLYMER POROUS-COATED UNCEMENTED PROSTHESIS
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 9329143
• Report Number: 0002249697-2019-03781
• Device Sequence Number: 419487
• Product Code: NPJ
• UDI-Device Identifier: 07613327026573
• UDI-Public: 07613327026573
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K141056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/08/2020

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 Catalogue Number: 5546-A-202
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/18/2019
• Supplement Date Received by Manufacturer: 12/11/2019
• Initial Report FDA Received Date: 11/15/2019
• Supplement Report FDA Received Date: 01/08/2020
• 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: 49 YR