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

Model Number	5532-G-319
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Discomfort (2330)
Date of Event	04/22/2020
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 similar events for the lot referenced.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.The following devices were also listed in this report: simplex p with tobramycin 1 pack; cat #: 6197-9-001; lot #: mha062.Triathlonctrfemconeaug sz3&4l; cat #: 5549-a-641; lot #: k2nh.Triathlon cemented stem-15mm x 50mm; cat #: 5560-s-115; lot #: 0100738l.Tri ts femur sz3 left; cat #: 5512-f-301; lot #: d3h9u.Triathlon stem extender 25mm; cat #: 5571-s-025; lot #: x42m4a.Triathlon femoral distal augment 5mm - size 3 left; cat #: 5540-a-301; lot #: b9x7d.Triathlon femoral distal augment 5mm - size 3 left; cat #: 5540-a-301; lot #: dei3g.Tri post augment sz3 5mm; cat #: 5543-a-300; lot #: dyd9e.Tri post augment sz3 5mm; cat #: 5543-a-300; lot #: d3g9i.Triathlon prim tib baseplate - cemented; cat #: 5520-b-300; lot #: yzbj.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.
Event or Problem Description
In response to follow-up, an exam note from (b)(6) 2020 noted: ".She experiences mild discomfort at the lateral joint line and into the distal it band.She is able to walk comfortably but struggles as the distance becomes greater." the reported treatment plan includes formal physical therapy.

• Brand Name: TRIATHLON PS X3 TIBIAL INSERT
• 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: 10161522
• Report Number: 0002249697-2020-01199
• Device Sequence Number: 3045423
• Product Code: MBH
• UDI-Device Identifier: 07613327050660
• UDI-Public: 07613327050660
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K141056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/17/2020

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: 09/30/2021
• Device Model Number: 5532-G-319
• Device Catalogue Number: 5532-G-319
• Device Lot Number: 136J1M
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/28/2020
• Initial Report FDA Received Date: 06/17/2020
• 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: Other
• Patient Age: 80 YR
• Patient Weight: 62