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

Model Number	5520-B-300
Medical Device Problem Code	Scratched Material (3020)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	10/17/2019
Type of Reportable Event	Malfunction
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
It was reported that, during a tka, our sales staff noticed a scuff on the tibial tray.A spare was used instead.
Additional Manufacturer Narrative
An event regarding an appearance issue (scratch marks) involving a triathlon baseplate was reported.The reported event was confirmed based on evaluation of the returned device.Method & results: device evaluation and results: review of primary cemented fixed bearing baseplate component, catalogue # 5520-b-300, lot code hxa3l confirmed three parallel lines on the baseplate surface.Characterisation using stereo microscopy and electron microscopy confirmed lines were due to plastic deformation of the metal.No evidence of foreign or embedded material was observed in the deformed areas that would indicate a potential cause of the deformation.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: review of primary cemented fixed bearing baseplate component, catalogue # 5520-b-300, lot code hxa3l confirmed three parallel lines on the baseplate surface.There are three parallel marks approximately 13433 ¿m in length and each line approximately 400-500 m in width.Stereo microscope examination confirmed the damage on the surface to be mechanical deformation of the surface.No evidence of foreign or embedded material was observed in the deformed areas that would indicate a potential cause of the deformation.The product manufacturing cell representative (baseplates) reviewed the event and thoroughly investigated all process steps that the baseplate passes through after component blasting i.E.Final inspection prior to transfer to the packaging cell.Following an investigation into the tools at final inspection, it was concluded that there is no tooling that could have caused this defect.See attached memo.The product manufacturing cell representative (packaging) reviewed the event and thoroughly investigated all process steps that the baseplate passes through i.E.The amsonic line and metals clean room (inner & outer blister).The provided memo concluded: the clean & passivate or skin pack & cut process does not provide an opportunity for a part to be scuff or marked similar to that identified on the customer complaint part.Furthermore, there were no events listed in the pass down notes or on the pemac history that indicated that the product could have got damaged, when this batch was processed through the packaging cell.Finally, operators involved in processing the batch, do not recall the scuff mark or any event that could have led to this event.See attached memo.While the event itself was confirmed, the exact cause of the event could not be determined.As detailed above, evaluation of the markings on the returned part by a materials engineer indicated no evidence of foreign or embedded material was observed in the deformed areas that would indicate a potential cause of the deformation.A thorough evaluation of the impacted manufacturing areas was also undertaken and again, could not determine any source of the reported issue within the manufacturing facility.It must be noted that the inner blister of the product was opened prior to identification of the reported issue.No further investigation for this event is possible at this time, should additional information become available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
It was reported that, during a tka, our sales staff noticed a scuff on the tibial tray.A spare was used instead.

• Brand Name: TRIATHLON PRIM TIB BASEPLATE - CEMENTED
• Common Device Name: PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 9322950
• Report Number: 0002249697-2019-03766
• Device Sequence Number: 16245900
• Product Code: MBH
• UDI-Device Identifier: 07613327050318
• UDI-Public: 07613327050318
• Combination Product (Y/N): N
• PMA/510(K) Number: K141056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2024
• Device Model Number: 5520-B-300
• Device Catalogue Number: 5520-B-300
• Device Lot Number: HXA3L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/06/2019
• Initial Date Received by Manufacturer: 10/17/2019
• Supplement Date Received by Manufacturer: 01/09/2020
• Initial Report FDA Received Date: 11/14/2019
• Supplement Report FDA Received Date: 02/05/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other