MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON #4 PS INSERT 9MM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Model Number	5532-P-409
Medical Device Problem Codes	Material Deformation (2976); Naturally Worn (2988)
Health Effect - Clinical Code	Injury (2348)
Date of Event	11/06/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Review of the product history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other events for the lot referenced.It was noted that the device is not available for evaluation.Should additional information become available, the evaluation summary will be submitted in a supplemental report.
Event or Problem Description
Whilst resurfacing patella of existing triathlon total knee replacement, surgeon decided to replace ps insert for a thicker size.On removal, the insert appeared to have pitting on articular surface and uneven surface on the back of the ps insert post.
Event or Problem Description
Whilst resurfacing patella of existing triathlon total knee replacement, surgeon decided to replace ps insert for a thicker size.On removal, the insert appeared to have pitting on articular surface and uneven surface on the back of the ps insert post.
Additional Manufacturer Narrative
An event regarding wear involving a triathlon insert was reported.The event was confirmed via evaluation of the returned device.Method & results product evaluation and results: visual inspection was performed as part of the material analysis report mar, dated 20-jan-2020.The returned device was examined with the aid of a stereomicroscope at magnifications up to 50x.The locking wire was not returned.This inspection indicated that the material loss observed on the post was consistent with delamination.The damage on the articulating surface of the insert was consistent with burnishing, scratching, delamination, and third body indentations; which are common damage modes of uhmwpe.The yellow discoloration of the insert is consistent with absorption of synovial fluid.Based on the given information, no identifiable materials or manufacturing discrepancies were observed on the surfaces examined.Medical records received and evaluation: a review of the provided medical records by a clinical consultant stated the following comment: cannot confirm event, need additional information; primary and revision operative reports, clinical and past medical history, additional serial dated x-rays and examination of explanted components.Product history review: a review of the device manufacturing records indicate that all devices accepted into final stock were free from discrepancies.Complaint history review: there have been no other similar events for the lot referenced.Conclusions: visual inspection of the returned device indicated that the material loss observed on the post was consistent with delamination.The damage on the articulating surface of the insert was consistent with burnishing, scratching, delamination, and third body indentations; which are common damage modes of uhmwpe.The yellow discoloration of the insert is consistent with absorption of synovial fluid.Based on the given information, no identifiable materials or manufacturing discrepancies were observed on the surfaces examined.The exact cause of the event could not be determined because insufficient information was provided.Further information such as primary and revision operative reports, clinical and past medical history and additional serial dated x-rays are needed to complete the investigation for determining root cause.No further investigation for this event is possible at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.

• Brand Name: TRIATHLON #4 PS INSERT 9MM
• 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: 9411854
• Report Number: 0002249697-2019-03940
• Device Sequence Number: 2929755
• Product Code: MBH
• UDI-Device Identifier: 07613327042764
• UDI-Public: 07613327042764
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K141056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/11/2020

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: 01/31/2013
• Device Model Number: 5532-P-409
• Device Catalogue Number: 5532P409
• Device Lot Number: LAZ816
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/03/2020
• Initial Date Received by Manufacturer: 11/06/2019
• Supplement Date Received by Manufacturer: 02/12/2020
• Initial Report FDA Received Date: 12/04/2019
• Supplement Report FDA Received Date: 03/11/2020
• 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: Hospitalization; Required Intervention
• Patient Age: 72 YR
• Patient Weight: 80