MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRI TS BASEPLATE SIZE 4; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number	5521-B-400
Medical Device Problem Codes	Unstable (1667); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Pain (1994)
Date of Event	04/19/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
Left knee complaints of radiating pain, locking and popping sensations with instability.Revised (b)(6) 2018 with tibial periprosthetic fracture noted.Tibial baseplate and insert were revised.
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
Left knee complaints of radiating pain, locking and popping sensations with instability.Revised (b)(6) 2018 with tibial periprosthetic fracture noted.Tibial baseplate and insert were revised.
Additional Manufacturer Narrative
Reported event: an event regarding periprosthetic fracture involving a triathlon baseplate was reported.The event was confirmed.Method & results: product evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device was not returned.Clinician review: a review with a clinical consultant indicated confirmation of event: i can confirm that the patient had a primary cemented triathlon implant since i was able to see the x-rays of the implant with the metaphyseal fracture.I was also able to see the stryker original stickers.I can also confirm the revision procedure since i was able to review the operation report and the original stryker stickers.Root cause analysis: the root cause of this event cannot be determined with certainty.Causes of late metaphyseal periprosthetic fracture are multi-factorial including surgical technique in the way that the tibia is prepared and the implant inserted and patient factors including activity level and bmi.In the history given, the patient was having pain prior to going on a vacation.She then got up from a low beach chair and the pain exacerbated.In the office notes it states that she did have a small fracture of the medial portion of the tibia approximately four months prior to the periprosthetic fracture being diagnosed.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 periprosthetic fracture of the tibia.A review with a clinical consultant indicated confirmation of event: i can confirm that the patient had a primary cemented triathlon implant since i was able to see the x-rays of the implant with the metaphyseal fracture.I was also able to see the stryker original stickers.I can also confirm the revision procedure since i was able to review the operation report and the original stryker stickers.The root cause of this event cannot be determined with certainty.Causes of late metaphyseal periprosthetic fracture are multi-factorial including surgical technique in the way that the tibia is prepared and the implant inserted and patient factors including activity level and bmi.In the history given, the patient was having pain prior to going on a vacation.She then got up from a low beach chair and the pain exacerbated.In the office notes it states that she did have a small fracture of the medial portion of the tibia approximately four months prior to the periprosthetic fracture being diagnosed.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: TRI TS BASEPLATE SIZE 4
• 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: anna ryan ; raheen business park; limerick NA ; EI NA ; 61498200
• MDR Report Key: 19528871
• Report Number: 0002249697-2024-00884
• Device Sequence Number: 7604395
• Product Code: MBH
• UDI-Device Identifier: 07613327026061
• UDI-Public: 07613327026061
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K141056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/19/2024

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: 12/31/2015
• Device Catalogue Number: 5521-B-400
• Device Lot Number: BVRP
• 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: 06/25/2024
• Initial Report FDA Received Date: 06/13/2024
• Supplement Report FDA Received Date: 07/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/29/2010
• 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: Required Intervention; Hospitalization
• Patient Age: 70 YR
• Patient Sex: Female
• Patient Weight: 96 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White