MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON #4 CR INSERT 11MM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, C

Model Number	5530-P-411
Medical Device Problem Codes	Fracture (1260); Naturally Worn (2988)
Health Effect - Clinical Codes	Failure of Implant (1924); Injury (2348)
Date of Event	12/12/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If additional information is received, it will be provided in a supplemental report upon completion of the investigation.
Event or Problem Description
It was reported that the patient's right knee was revised due to failure of the poly insert (reported as having been worn completely through).The 4x11 cr poly insert was revised to a 4x11 x3 cr poly insert.Rep reported he has additional images and the explant for return, and confirmed that no further information will be available.
Event or Problem Description
It was reported that the patient's right knee was revised due to failure of the poly insert (reported as having been worn completely through).The 4x11 cr poly insert was revised to a 4x11 x3 cr poly insert.Rep reported he has additional images and the explant for return, and confirmed that no further information will be available.
Additional Manufacturer Narrative
An event regarding crack/fracture involving a triathlon insert was reported.The event was confirmed through product evaluation.Method & results: product evaluation and results: visual inspection of the returned device noted the following: the posterior portion of the medial condyle had fractured from the main body of the insert.The damage present on the articulating surface is consistent with burnishing, scratching, and third body indentations; these are common damage modes of uhmwpe.The posterior portion of the medial condyle was worn and had fractured.The fracture morphology is consistent with an overload fracture.Material analysis of the returned device indicated the following: the damage on the articulating surface of the insert was consistent with burnishing,scratching, delamination, and third body indentations; which are common damage modes ofuhmwpe.The posterior portion of the medial condyle was worn and had fractured in overload.Based on the given information, no identifiable materials or manufacturing discrepancieswere 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: "re pi (b)(6) which represents a female patient, dob (b)(6) 1960 described as 65 inches tall and weighing 371 pounds.She underwent a tka on approximately (b)(6) 2007 which was revised on (b)(6) 2019.The event description states: "right knee was revised due to failure of poly insert reported as "worn completely through".A 4/11 cr insert was revised to a 4/11 x3 cr poly." undated x-ray ap and lateral right knee demonstrates a cemented cr tka, well fixed components , reduced with the medial joint space narrower than the lateral.No clinical or pmh, no operative reports and no examination of the explanted component.In this morbidly obese patient, 13 years after tka, some poly wear in not unexpected, particularly if alignment and soft tissue balance is not optimal.No determination of the cause of the described event description can be made based on only 2 undated x-rays of the tka." 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: given the review of the material analysis report and comments provided by the clinical consultant, there is evidence that the fracture was likely caused by overload condition due to the patient factors as described.However, this could not be definitive because insufficient information was provided.Further information such as pathology reports, pre- and post-operative x-rays and the primary operative report as well as patient history and follow-up notes 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 CR INSERT 11MM
• Common Device Name: PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, C
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 9569768
• Report Number: 0002249697-2020-00068
• Device Sequence Number: 374569
• Product Code: MBH
• UDI-Device Identifier: 07613327041781
• UDI-Public: 07613327041781
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K141056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2007
• 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): 04/07/2020

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: 06/30/2011
• Device Model Number: 5530-P-411
• Device Catalogue Number: 5530P411
• Device Lot Number: LY884
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2020
• Initial Date Received by Manufacturer: 12/12/2019
• Supplement Date Received by Manufacturer: 03/11/2020
• Initial Report FDA Received Date: 01/09/2020
• Supplement Report FDA Received Date: 04/08/2020
• 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: 59 YR
• Patient Weight: 168