MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH SERIES 7000 STANDARD TIBIA; PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER

Model Number	7115-0007
Medical Device Problem Code	Loss of Osseointegration (2408)
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	04/27/2022
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 was reported by the sale rep that surgeon informed that there's a possible revision surgery for knee replacement due to aseptic loosening as patient had the knee implant for about 10 years.
Event or Problem Description
It was reported by the sale rep that surgeon informed that there's a possible revision surgery for knee replacement due to aseptic loosening as patient had the knee implant for about 10 years.Updated: revision completed on (b)(6) 2022.
Additional Manufacturer Narrative
Reported event: an event regarding loosening involving a scorpio baseplate was reported.The event was not confirmed.Method & results: product evaluation and results: the reported device was not returned however photographs were provided for review.Visual inspection of the provided photographs show a recently explanted baseplate, femoral component, and insert.Blood, tissue, and bone residue are visible consistent with recent implantation.No evidence of device failure can be seen.Clinician review: a review of the provided medical information by a clinical consultant indicated: "as described above, this inquiry concerns a primary cemented posteriorly stabilized scorpio total knee arthroplasty that was revised approximately 10 years after implantation for aseptic loosening.The revision was performed using a rotating hinge implant.I cannot confirm that this event occurred although it does state a revision was carried out in the summary.The x-rays that were supplied from my review had no date on them.While there was some stress shielding and or osteolysis present on the femoral side, in my experience this is not unusual with long-term follow-up of scorpio implants.The bone cement interface appears satisfactory with no radiolucencies at the bone cement interface.There have been cases where x-rays are relatively normal but debonding of the implant has been found.Without the operative report or intraoperative photos there can be no certainty.The surgeon revised this knee with a modular rotating hinge which in my opinion would not be necessary except in specific circumstances.I see no significant bone loss.Even in the face of the stress shielding or osteolysis i believe there would be adequate bone stock for a standard revision with a ts component with augments and cones if needed.A hinge would be used when the ligament envelope is incompetent.I cannot determine the root cause of this event with certainty.I would need to have evidence of loosening either with a ct scan, intraoperative photos, and the revision operation report.Causes of debonding, osteolysis and aseptic loosening are multifactorial including surgical technique, patient factors including bmi and activity level and implant factors." product history review: review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.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 aseptic loosening of the baseplate.A review of the provided medical information by a clinical consultant indicated: "as described above, this inquiry concerns a primary cemented posteriorly stabilized scorpio total knee arthroplasty that was revised approximately 10 years after implantation for aseptic loosening.The revision was performed using a rotating hinge implant.I cannot confirm that this event occurred although it does state a revision was carried out in the summary.The x-rays that were supplied from my review had no date on them.While there was some stress shielding and or osteolysis present on the femoral side, in my experience this is not unusual with long-term follow-up of scorpio implants.The bone cement interface appears satisfactory with no radiolucencies at the bone cement interface.There have been cases where x-rays are relatively normal but debonding of the implant has been found.Without the operative report or intraoperative photos there can be no certainty.The surgeon revised this knee with a modular rotating hinge which in my opinion would not be necessary except in specific circumstances.I see no significant bone loss.Even in the face of the stress shielding or osteolysis i believe there would be adequate bone stock for a standard revision with a ts component with augments and cones if needed.A hinge would be used when the ligament envelope is incompetent.I cannot determine the root cause of this event with certainty.I would need to have evidence of loosening either with a ct scan, intraoperative photos, and the revision operation report.Causes of debonding, osteolysis and aseptic loosening are multifactorial including surgical technique, patient factors including bmi and activity level and implant factors." 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: SERIES 7000 STANDARD TIBIA
• 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-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer Contact: diana rogers ; 210 centennial avenue; centennial park, elstree; borehamwood WD6 3-SJ ; UK WD6 3SJ ; 2082386500
• MDR Report Key: 14446463
• Report Number: 0002249697-2022-00718
• Device Sequence Number: 11906337
• Product Code: KRO
• UDI-Device Identifier: 07613327033366
• UDI-Public: 07613327033366
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• PMA/510(K) Number: K910990
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/12/2022

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: 02/28/2015
• Device Model Number: 7115-0007
• Device Catalogue Number: 7115-0007
• Device Lot Number: MJATMY
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/27/2022
• Supplement Date Received by Manufacturer: 11/29/2022
• Initial Report FDA Received Date: 05/19/2022
• Supplement Report FDA Received Date: 12/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/23/2010
• 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: Hospitalization; Required Intervention
• Patient Age: 82 YR
• Patient Sex: Female