MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH NO 7. TRIATHLON TS PLUS TIBIAL INSERT X3 POLY 13MM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Model Number	5537-G-713
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	03/05/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Reported event: an event regarding dislocation involving a triathlon insert was reported.The event was not confirmed.Method & results: product evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as product was not returned.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 lot referenced.Conclusion: 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
As reported: "pt.Presented to the ed with a dislocated right-knee.He received an insert swap and washout of the same knee back on (b)(6) 2020 due to his wound opening." spoke to rep: confirmed that no further information would be released by the hospital or surgeon.

• Brand Name: NO 7. TRIATHLON TS PLUS TIBIAL INSERT X3 POLY 13MM
• 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: 11573559
• Report Number: 0002249697-2021-00540
• Device Sequence Number: 11668196
• Product Code: MBH
• UDI-Device Identifier: 07613327027488
• UDI-Public: 07613327027488
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K141056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/26/2021

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: 11/30/2021
• Device Model Number: 5537-G-713
• Device Catalogue Number: 5537-G-713
• Device Lot Number: 7N39V2
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/05/2021
• Initial Report FDA Received Date: 03/26/2021
• 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