MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN_TIBIAL BASEPLATE; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Model Number	5530-G-309
Medical Device Problem Codes	Unstable (1667); Malposition of Device (2616)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	01/03/2023
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.A supplemental report will be submitted upon completion of the investigation.
Event or Problem Description
The following was reported: knee revision due to instability.
Additional Manufacturer Narrative
Reported event: an event regarding malposition involving an unknown baseplate was reported.The event was confirmed as the review of the medical records concluded: 'there was an x-ray that did show tibial malposition with marked posterior slope and apparent subluxation.' method & results: product evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device remained implanted.Clinician review:a review of the provided medical records by a clinical consultant indicated: narrative: there was a reported revision surgery of instability of a tka.There were no medical records documenting the patient¿s condition pre or postoperative course or exam.There were records showing that a primary knee was performed.X-rays prior to the implant showed medial compartmental oa.A tka was performed with triathlon uncemented implants.There were xrays approximately 5 years later showing the uncemented components without apparent loosening but marked tibial posterior slope on the lateral and possibly subluxation on the ap.A change in position cannot be determined without interval x-rays.An operative note was provided documenting revision surgery for instability but no additional details as to the patient condition or exam.A triathlon stemmed ts component was place with cement.No postoperative course was provided for review.Conclusion/assessment: revision knee performed for reported instability in an uncemented triathlon knee with malposition.Event confirmation: a revision surgery can be confirmed.Root cause: the root cause of the revision was reported to be instability.There was an x-ray that did show tibial malposition with marked posterior slope and apparent subluxation.Product history review: could not be performed as the device lot details were not provided.Complaint history review: could not be performed as the device lot details were not provided.Conclusions: the event was confirmed as the review of the medical records concluded: 'there was an x-ray that did show tibial malposition with marked posterior slope and apparent subluxation.' no further investigation for this event is possible at this time.If additional information become available to indicate further evaluation is warranted, this record will be reopened.H3 other text : device remains implanted.
Event or Problem Description
The following was reported: knee revision due to instability.Update 23 mar 2023 - based on the conclusion of the medical review, the clinician stated: 'the root cause of the revision was reported to be instability.There was an x-ray that did show tibial malposition with marked posterior slope and apparent subluxation.'.

• Brand Name: UNKNOWN_TIBIAL BASEPLATE
• Common Device Name: PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
• 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: 16534993
• Report Number: 0002249697-2023-00247
• Device Sequence Number: 5993235
• Product Code: MBH
• UDI-Device Identifier: 07613327050431
• UDI-Public: 07613327050431
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: K141056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/20/2023

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: 09/30/2020
• Device Model Number: 5530-G-309
• Device Catalogue Number: 5530-G-309
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 02/27/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/14/2023
• Supplement Date Received by Manufacturer: 03/24/2023
• Initial Report FDA Received Date: 03/13/2023
• Supplement Report FDA Received Date: 04/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/14/2015
• 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: 69 YR
• Patient Sex: Female
• Patient Weight: 75 KG