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

Catalog Number 5520-B-600

Device Problem Scratched Material (3020)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/14/2019

Event Type  malfunction  

Manufacturer Narrative

Review of the device history records indicate devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.

Event Description

Before the surgeon was ready to cement in the baseplate he recognized two distinct lines on the bottom surface of the baseplate.

Event Description

Before the surgeon was ready to cement in the baseplate he recognized two distinct lines on the bottom surface of the baseplate.Update: "issue resolved by opening and using a different baseplate.1 minute delay for opening a new baseplate.".

Manufacturer Narrative

An event regarding an appearance issue (lines) involving a triathlon baseplate was reported.The reported lines were visible however the product was not returned to confirm whether it was visually and dimensionally within specification.Method & results: device evaluation and results: the reported device was not returned however photographs were provided for review.The photographs show two lines on the underside of the baseplate on either side of the keel.The images were provided to the manufacturing cell for review who indicated: it was determined that the two lines were parting lines created during the wax injection and casting operations within the investment casting cell.Parting lines are an indication of where the two halves of the injection mold make contact when assembled.Per the approved process flow, these lines are removed from the casted baseplates further downstream within the tibial metals cell via a 24-grit and glass bead blast to achieve a final satin finish.Clinician review: no medical records were received for review with a clinical consultant device history review: all 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 reported lot.Conclusion: the product manufacturing cell representative reviewed the event and indicated the following: as documented on the communication log tab of the complaint record, the device was not returned from the hospital to a stryker site; however, a photo was provided by the sale representative of the observed lines.Based on this photo included in the complaint record, it was determined that the two lines were parting lines created during the wax injection and casting operations within the investment casting cell.Parting lines are an indication of where the two halves of the injection mold make contact when assembled.Per the approved process flow, these lines are removed from the casted baseplates further downstream within the tibial metals cell via a 24-grit and glass bead blast to achieve a final satin finish.From the device history record (dhr) of the investment casting cell semi-finished (sf) lot (p/n 5520-b-600sf, lot dg49r), it was found that the product was wax injected on 08 nov 2018 and cast on 20 nov 2018.From the dhr of the tibial metals saleable-level item, it was found that the product was 24-grit blasted, glass bead blasted, and final inspected on 15 jan 2019.All five (5) noted operations were completed without any scrap or rework needed.In addition, a review of the inspection guide sheet (igs) for documenting the final finish acceptance activity indicates that all parts within lot dg49rb had an acceptable satin finish.This visual acceptance activity is completed at a 100% inspection frequency.The final inspectors within the tibial metals cell perform their final inspection to procedure ts3-10-007 specification for visual standards for implantable device (current rev.10), as indicated by the 5520-b-600 router template.All final inspectors within the tibial metals cell are trained to the procedure via compliance wire read-and-sign, as well as on the job training.Section 7.8 of the procedure dictates visual inspection of a non-bearing surface of an implantable device, which is applicable to this event as the parting lines were found on the nonbearing underside of the baseplate.Subsection 7.8.3 requires that ¿minor residual processing and/or finishing imperfections that do not catch a fingernail are acceptable¿.Residual parting lines are considered processing and/or finishing imperfections, as they are removed during processing and finishing of the implant; therefore, any residual parting line that does not catch the fingernail of the inspector may be considered acceptable.Due to the fact that the device was not returned by the hospital, the device cannot be re-inspected to specification ts3-10-007, subsection 7.8.3.Therefore, it cannot be confirmed that the residual parting lines observed by the surgeon are nonconforming.As a result, this complaint record shall not escalate to the initiation of a nonconformance record.While it was confirmed that the reported lines were visible, the product was not returned to confirm whether it was visually and dimensionally within specification.No further investigation for this event is possible at this time as no devices and/ or insufficient information was received by stryker.If devices and / or additional information become available to indicate further evaluation is warranted, this record will be reopened.

• Brand Name: TRIATHLON PRIM TIB BASEPLATE - CEMENTED
• Type of Device: PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 8693217
• MDR Text Key: 148175465
• Report Number: 0002249697-2019-02240
• Device Sequence Number: 1
• Product Code: MBH
• UDI-Device Identifier: 07613327050349
• UDI-Public: 07613327050349
• Combination Product (y/n): N
• PMA/PMN Number: K141056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Type of Report: Initial,Followup
• Report Date: 09/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/12/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2024
• Device Catalogue Number: 5520-B-600
• Device Lot Number: DG49RB
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/30/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other