MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON PRIM CEM FXD BPLT #5; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, C

Catalog Number	5520B500
Medical Device Problem Codes	Osseointegration Problem (3003); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Injury (2348); Osteolysis (2377)
Date of Event	09/08/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An event regarding revision due to degenerative arthritis involving a triathlon insert was reported.The event was not confirmed.Method & results: device evaluation and results: not performed as the product was not returned.Medical records received and evaluation: not performed as medical records were not provided.Device history review: indicated all devices were manufactured and accepted into final stock with no reported discrepancies.Complaint history review: there have been no other similar events for the lot referenced.The following devices were also listed in this report: triathlon symmetric x3 patella; cat# 5550-g-319; lot# e5l2; triathlon prim cem fxd bplt #5; cat# 5520b500; lot# s4jcm; triathlon ps fem component, cemented; cat# 5515-f-402; lot# dmuj; it cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.Conclusions: the information in this report was provided by stryker orthopaedics legal affairs department.The exact cause of the event could not be determined because insufficient information was provided.Additional information including operative reports, progress notes, x-rays and return of the device are needed to fully investigate the event.If further information becomes available or the product is returned, this investigation will be re-opened.
Event or Problem Description
It was reported that allegedly the patient was revised due to "degenerative arthritis, right knee".
Event or Problem Description
It was reported through the communication of an attorney that allegedly the patient was revised due to "degenerative arthritis, right knee".Update 03 july 2019 - conclusion of medial review confirmed ; review of these records confirm revision surgery for aseptic loosening of a primary cemented tka tibial baseplate.
Additional Manufacturer Narrative
An event regarding revision due to degenerative arthritis involving a triathlon baseplate was reported.The event was not confirmed.However, a review of the medical records provided by a clinician confirmed baseplate loosening.Method & results: device evaluation and results: not performed as the product was not returned.Medical records received and evaluation: a review of the provided medical records and x-rays by a clinical consultant indicated:review of these records confirm revision.Surgery for aseptic loosening of a primary cemented tka tibial baseplate.The root cause for the aseptic loosening could not be determined as no imaging or orthopedic.Office notes temporally related to the revision were available for review.The bone loss ¿under the anterior flange and centrally around the condyles¿ is most likely related to bone removed in notching the anterior cortex and unrelated to the aseptic loosening of the tibia.Device history review: indicated all devices were manufactured and accepted into final stock with no reported discrepancies.Complaint history review: there have been no other similar events for the lot referenced.Conclusions: review of these records confirm revision surgery for aseptic loosening of a primary cemented tka tibial baseplate.The root cause for the aseptic loosening could not be determined as no imaging or orthopedic office notes temporally related to the revision were available for review.The bone loss ¿under the anterior flange and centrally around the condyles¿ is most likely related to bone removed in notching the anterior cortex and unrelated to the aseptic loosening of the tibia.The exact cause of the event could not be determined because insufficient information was provided.Additional information including imaging or orthopedic office notes and return of the device are needed to fully investigate the event.If further information becomes available or the product is returned, this investigation will be re-opened.

• Brand Name: TRIATHLON PRIM CEM FXD BPLT #5
• 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: 8421210
• Report Number: 0002249697-2019-01334
• Device Sequence Number: 16686905
• Product Code: MBH
• UDI-Device Identifier: 07613327050806
• UDI-Public: 07613327050806
• 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: 2011
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/29/2019

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 Expiration Date: 05/31/2016
• Device Catalogue Number: 5520B500
• Device Lot Number: S4JCM
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/15/2019
• Supplement Date Received by Manufacturer: 07/04/2019
• Initial Report FDA Received Date: 03/14/2019
• Supplement Report FDA Received Date: 07/29/2019
• 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: 68 YR