MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH NRG KNEE P/S NRG BEARING INSERT SIZE; PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER

Model Number	82-3-0910
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/18/2022
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.Device not returned.
Event or Problem Description
It has been reported "in a patient with nrg knee replacement, the x3 insert was broken, the patient required a second operation.".
Event or Problem Description
It has been reported "in a patient with nrg knee replacement, the x3 insert was broken, the patient required a second operation.".
Additional Manufacturer Narrative
Reported event: an event regarding crack/fracture involving a scorpio insert was reported.The event was confirmed via evaluation of provided photographs of the event.Method & results: product evaluation and results: the reported device was not returned however photographs were provided for review.Visual inspection of the provided photographs of the device indicate that the post of the insert has fractured off.Blood is also visible on the device.Additional damage consistent with explantation is present.Clinician review: a review of the provided medical information by a clinical consultant indicated: "the x-rays show a tka with an asymmetric joint space consistent with advanced wear or breakage of the tibial insert.Wear or breakage of a tibial insert necessitating revision surgery is confirmed.The root cause of this mechanical failure cannot be determined from this limited documentation." complaint history review: there have been no other similar events for the lot referenced.Conclusions: it was reported that the patient was revised due to fracture of the scorpio insert.The reported device was not returned however photographs were provided for review.Visual inspection of the provided photographs of the device indicate that the post of the insert has fractured off.Blood is also visible on the device.Additional damage consistent with explantation is present.A review of the provided medical information by a clinical consultant indicated: "the x-rays show a tka with an asymmetric joint space consistent with advanced wear or breakage of the tibial insert.Wear or breakage of a tibial insert necessitating revision surgery is confirmed.The root cause of this mechanical failure cannot be determined from this limited documentation." 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.

• Brand Name: NRG KNEE P/S NRG BEARING INSERT SIZE
• Common Device Name: PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-CORK; ida industrial estate; carrigtwohill NJ NA ; EI NA
• Manufacturer Contact: arokiya raj ; 325 corporate drive; centennial park, elstree; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 14748429
• Report Number: 0002249697-2022-00869
• Device Sequence Number: 4878348
• Product Code: KRO
• UDI-Device Identifier: 04546540364494
• UDI-Public: 04546540364494
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K030978
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/23/2023

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: 03/28/2026
• Device Model Number: 82-3-0910
• Device Catalogue Number: 82-3-0910
• Device Lot Number: 80500801
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/26/2022
• Supplement Date Received by Manufacturer: 02/03/2023
• Initial Report FDA Received Date: 06/20/2022
• Supplement Report FDA Received Date: 02/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/10/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 73 YR
• Patient Sex: Male