MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH X3 TRIATHLON CS INSERT #7 13MM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number	5531G713
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Unspecified Infection (1930); Pain (1994); Injury (2348)
Date of Event	05/18/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other events for the reported lot.There have been no other events for the sterile lot referenced.It was noted that the device is not available for evaluation.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.The following devices were also listed in this report: triathlon cr fem comp #7 l-cem; 5510f701; b6t2h; triathlon prim cem fxd bplt #7; 5520b700; cc93a; triathlon symmetric x3 patella; 5550-g-391; l1m6; it cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.Device not returned.
Event or Problem Description
As reported: "all 4 triathlon components removed for infection.Patient received temporary cement spacer until infection clears.".
Event or Problem Description
As reported: "all 4 triathlon components removed for infection.Patient received temporary cement spacer until infection clears.".
Additional Manufacturer Narrative
Expiration date corrected.An event regarding infection 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 for evaluation.Medical records received and evaluation: not performed as no medical records were provided for review.Device history review: indicate all devices were manufactured and accepted into final stock on with no reported discrepancies.Complaint history review: there have been no other events for the lot or sterile lot referenced.Conclusion: the exact cause of the event could not be determined because insufficient information was provided.Further information such as device 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 needed to complete the investigation for determining a root cause.No further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this investigation will be reopened.

• Brand Name: X3 TRIATHLON CS INSERT #7 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: 7601969
• Report Number: 0002249697-2018-01812
• Device Sequence Number: 1799694
• Product Code: MBH
• UDI-Device Identifier: 07613327046014
• UDI-Public: 07613327046014
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K141056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 07/26/2018

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: 04/30/2022
• Device Catalogue Number: 5531G713
• Device Lot Number: LFT547
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/18/2018
• Supplement Date Received by Manufacturer: 06/28/2018
• Initial Report FDA Received Date: 06/14/2018
• Supplement Report FDA Received Date: 07/26/2018
• 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 Weight: 116