MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UNIX UNI KNEE TIB BEAR INSERT; PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number	4540-0308
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Inflammation (1932); Pain (1994); Injury (2348); Reaction (2414)
Date of Event	05/22/2019
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 have been no other similar events for the lot referenced.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
Revision of unix unilateral knee replacement performed in 2015.Original implant was revised on (b)(6) 2019 due to severe poly wear resulting in metallosis.Dr.Removed the existing unix knee and revised with a triathlon total knee replacement (cr femur with stemmed tibia).Update (b)(6) 2019 (b)(6): as reported in how was issue noticed "issue was identified prior to medical procedure when the surgeon performed a knee arthroscopy to identify the patient¿s complaints of pain and metallosis was observed".
Event or Problem Description
Revision of unix unilateral knee replacement performed in 2015.Original implant was revised on 22/5/19 due to severe poly wear resulting in metallosis.Dr.Removed the existing unix knee and revised with a triathlon total knee replacement (cr femur with stemmed tibia).Update 24/may/2019 wg: as reported in how was issue noticed "issue was identified prior to medical procedure when the surgeon performed a knee arthroscopy to identify the patient¿s complaints of pain and metallosis was observed".
Additional Manufacturer Narrative
An event regarding crack/fracture involving an unix insert was reported.The event was confirmed by inspection of the received image of the device.Method & results: -device evaluation and results: the device was not returned.Visual inspection of the provided image of the device noted that the device was fractured from the lateral edge.Dimensional, functional and material analysis could not be performed as the device was not returned.-clinician review: no medical records were received for review with a clinical consultant.-device history review: review indicated all devices were manufactured and accepted into final stock with no reported discrepancies.-complaint history review: there have been no other similar events for the lot.Conclusions: it was reported that the patient's knee was revised due to severe ploy wear resulting in metallosis.Patient also complained of pain.Visual inspection of the provided image of the device noted that the device was fractured from the edge.The root cause could not be determined because the devices were not returned for evaluation and insufficient information was provided.Further information such as return of device, pre- and post-op x- rays, patient history, pathology report & follow-up notes are needed to investigate this event further.If additional information and/or device becomes available, this investigation will be reopened.

• Brand Name: UNIX UNI KNEE TIB BEAR INSERT
• Common Device Name: PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 8705968
• Report Number: 0002249697-2019-02277
• Device Sequence Number: 16642299
• Product Code: HRY
• UDI-Device Identifier: 07613327101454
• UDI-Public: 07613327101454
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K923011
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• 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): 08/08/2019

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: 02/29/2020
• Device Catalogue Number: 4540-0308
• Device Lot Number: CPPPK05
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/22/2019
• Supplement Date Received by Manufacturer: 07/12/2019
• Initial Report FDA Received Date: 06/17/2019
• Supplement Report FDA Received Date: 08/08/2019
• 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: 63 YR