MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON CR X3 TIBIAL INSERT; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, C

Catalog Number	5530-G-613
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Unspecified Infection (1930); Injury (2348)
Date of Event	12/23/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A review of the device history records indicates that the reported devices were manufactured and accepted into final stock with no reported discrepancies.The complaint history review indicated that there were no similar events for the reported lot.It was noted that the device is not available for evaluation.Should additional information become available, 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.A 6x13 cr insert was exchanged for the same catalog number.Rep reported that no further information will be released.
Event or Problem Description
It was reported that the patient's right knee was revised.A 6 x 13 cr insert was exchanged for the same catalog number.Rep reported that no further information will be released.Update: rep has indicated revision due to infection.
Additional Manufacturer Narrative
An event regarding infection involving a triathlon insert was reported.The event was not confirmed.Method & results: product evaluation and results: not performed as no product was returned for evaluation.Clinician review: no medical records were received for review with a clinical consultant.Product history review: indicated 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.Conclusions: the event itself could not be confirmed and exact cause of the event could not be determined because insufficient information was provided.Further information such as product return, pre and post operative x-rays, operative reports, pathology reports including the strain of infection identified as well as patient history and follow up notes are required to complete the investigation for determining a root cause.The following devices were also listed in this report after the initial mdr was filed: triathlon cr fem comp #5 r-cem; cat# 5510f502; lot# d6s9a.Triathlon prim tib baseplate - cemented; cat# 5520-b-600; lot# by39va.Triathlon asymmetric x3 patella; cat# 5551-g-350; lot# 84r8.Sterile fluted headless 1/8" pin 3.5" long; cat# 7650-2038a; lot# rdcv127d.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.No further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.

• Brand Name: TRIATHLON CR X3 TIBIAL INSERT
• 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: 8260623
• Report Number: 0002249697-2019-00228
• Device Sequence Number: 1911871
• Product Code: MBH
• UDI-Device Identifier: 07613327050608
• UDI-Public: 07613327050608
• 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: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/22/2019

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: 05/31/2021
• Device Catalogue Number: 5530-G-613
• Device Lot Number: 3J2HXP
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/23/2018
• Supplement Date Received by Manufacturer: 02/22/2019
• Initial Report FDA Received Date: 01/18/2019
• Supplement Report FDA Received Date: 03/22/2019
• 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: 60 YR