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

Catalog Number	7115-0009
Medical Device Problem Codes	Unstable (1667); Loss of Osseointegration (2408)
Health Effect - Clinical Codes	Pain (1994); Inadequate Osseointegration (2646)
Date of Event	05/31/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient came to dr.In (b)(6) 2018 with complaints of ongoing left knee pain for about 1 year.Over the last year with increasing instability, clicking and buckling feeling.Revised to a triathlon knee (b)(6) 2018 with collapsed tibia noted.
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
Patient came to dr.In (b)(6) 2018 with complaints of ongoing left knee pain for about 1 year.Over the last year with increasing instability, clicking and buckling feeling.Revised to a triathlon knee (b)(6) 2018 with collapsed tibia noted.
Additional Manufacturer Narrative
Reported event: an event regarding loosening involving a scorpio baseplate was reported.The event was confirmed.Method & results: product evaluation and results: visual inspection, dimensional, functional and material analysis could not be performed as the device was not returned.Clinician review: a review of the provided medical information by a clinical consultant indicated: "confirmation of event: i can confirm that the patient had a primary scorpio total knee arthroplasty since i was able to see the failed implant on x-ray.I can also confirm that the patient underwent revision surgery since i was able to review the revision operation report.No post revision x-rays were supplied.Root cause analysis: the root cause of loosening of a total knee implant approximately 12 1/2 years after the initial surgery cannot be determined with certainty.The causes of late loosening include surgical technique factors, mostly in the alignment and positioning and cementing of the implant, possibly infection, although in this case there was no evidence of infection, patient factors including activity level and bmi can play a role.With the information provided, i would not assign any causality to the implant itself.Product history review: review of the device history records indicate devices were manufactured and accepted into final stock on with no relevant reported discrepancies.Complaint history review: there have been no other similar events for the lot referenced.Conclusions: a review of the provided medical information by a clinical consultant indicated: confirmation of event: i can confirm that the patient had a primary scorpio total knee arthroplasty since i was able to see the failed implant on x-ray.I can also confirm that the patient underwent revision surgery since i was able to review the revision operation report.No post revision x-rays were supplied.Root cause analysis: the root cause of loosening of a total knee implant approximately 12 1/2 years after the initial surgery cannot be determined with certainty.The causes of late loosening include surgical technique factors, mostly in the alignment and positioning and cementing of the implant, possibly infection, although in this case there was no evidence of infection, patient factors including activity level and bmi can play a role.With the information provided, i would not assign any causality to the implant itself.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, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• 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: marisol santiago ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 19528876
• Report Number: 0002249697-2024-00885
• Device Sequence Number: 18043441
• Product Code: JWH
• UDI-Device Identifier: 07613327033373
• UDI-Public: 07613327033373
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K910990
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2006
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/21/2024

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: 05/31/2012
• Device Catalogue Number: 7115-0009
• Device Lot Number: 1A5MJD
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/23/2024
• Supplement Date Received by Manufacturer: 06/26/2024
• Initial Report FDA Received Date: 06/13/2024
• Supplement Report FDA Received Date: 07/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/23/2007
• 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: 77 YR
• Patient Sex: Male
• Patient Weight: 112 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White