MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON PRIM CEM FXD BPLT #2; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number	5520B200
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Codes	Unspecified Infection (1930); Injury (2348); Inadequate Osseointegration (2646)
Date of Event	07/16/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An event regarding revision due to failed right total knee arthroplasty was reported.Clinician review of the provided medical records indicated incomplete cementation of the tibial baseplate as well as late onset hematogenous infection of the arthroplasty and arthroscopic debridement of the knee may have increased ligament laxity of the arthroplasty knee.The reported loosening and instability were confirmed however infection was not confirmed.Method & results: product evaluation and results: not performed as no product was returned for evaluation.Clinician review: a review of the provided medical records by a clinical consultant indicated: suboptimal initial device fixation through incomplete cementation of the tibial baseplate has contributed to loosening requiring revision surgery.It would be quite likely that a late onset low- grade infection of hematogenous origin has contributed as well to failure while prior to revision an extensive arthroscopic debridement of the knee may have contributed to increased ligament laxity thereby increasing complaints requiring more early intervention with revision surgery of all components, replaced with a competitor's device with an adequate end result.Product history review: indicate 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 lot or sterile lot referenced.The following devices were also listed in this report: triathlon symmetric x3 patella; cat#5550-g-278; lot#z563, triathlon cr fem comp #2 r-cem; cat#5510f202; lot#scfaj, it cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.Conclusion: a review of the provided medical records by a clinical consultant indicated: suboptimal initial device fixation through incomplete cementation of the tibial baseplate has contributed to loosening requiring revision surgery.It would be quite likely that a late onset low-grade infection of hematogenous origin has contributed as well to failure while prior to revision an extensive arthroscopic debridement of the knee may have contributed to increased ligament laxity thereby increasing complaints requiring more early intervention with revision surgery of all components, replaced with a competitor's device with an adequate end result.No further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.The information in this report was provided by stryker orthopaedics legal affairs department.No additional information is available at this time due to the ongoing litigation.Should additional information become available, the evaluation summary will be submitted in a supplemental report.
Event or Problem Description
It was reported through the communication of an attorney that allegedly the patient was revised due to "failed right total knee arthroplasty".Update (b)(6) 2019 by of, as per medical review: suboptimal initial device fixation through incomplete cementation of the tibial baseplate has contributed to loosening requiring revision surgery.It would be quite likely that a late onset low- grade infection of hematogenous origin has contributed as well to failure while prior to revision an extensive arthroscopic debridement of the knee may have contributed to increased ligament laxity thereby increasing complaints requiring more early intervention with revision surgery of all components, replaced with a competitor's device with an adequate end result.

• Brand Name: TRIATHLON PRIM CEM FXD BPLT #2
• 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: 9081721
• Report Number: 0002249697-2019-03242
• Device Sequence Number: 19553988
• Product Code: MBH
• UDI-Device Identifier: 07613327041569
• UDI-Public: 07613327041569
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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: 2016
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/18/2019

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 Catalogue Number: 5520B200
• Device Lot Number: SBX9J
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/22/2019
• Initial Report FDA Received Date: 09/18/2019
• 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: 81 YR