MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON CEMENTED STEM-15MM X 50MM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Model Number	5560-S-115
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Loss of Range of Motion (2032)
Date of Event	11/24/2020
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.
Event or Problem Description
It was reported that the patient's left knee was revised.As reported: "pt.Presented with pain and limited range-of-motion due to fibrotic/scar tissue formation.The tibial components were revised in order to address joint-tightness in both the extension and flexion gaps.Altogether, the tibia-baseplate, stem, and corresponding insert were swapped out.The ts cone augment was not removed, it remains in-place.No complaints have been filed against the implants, and no further information is available." the patient was revised from a size 6 triathon baseplate and stem (implanted (b)(6) 2020) with a 6 x 9 mm ts insert (implanted (b)(6) 2020) to a size 5 triathlon baseplate and stem with a 5 x 9 mm ts insert.Spoke to rep: confirmed there are no allegations against the revised liner and that no further information will be released by the hospital or surgeon.
Event or Problem Description
It was reported that the patient's left knee was revised.As reported: "pt.Presented with pain and limited range-of-motion due to fibrotic/scar tissue formation.The tibial components were revised in order to address joint-tightness in both the extension and flexion gaps.Altogether, the tibia-baseplate, stem, and corresponding insert were swapped out.The ts cone augment was not removed, it remains in-place.No complaints have been filed against the implants, and no further information is available." the patient was revised from a size 6 triathlon baseplate and stem (implanted on (b)(6) 2020) with a 6 x 9 mm ts insert (implanted on (b)(6) 2020) to a size 5 triathlon baseplate and stem with a 5 x 9 mm ts insert.Spoke to rep: confirmed there are no allegations against the revised liner and that no further information will be released by the hospital or surgeon.
Additional Manufacturer Narrative
Reported event:  an event regarding rom involving a triathlon stem was reported.  conclusion:  it was reported that the patient's left knee was revised for pain and limited range-of-motion due to fibrotic/scar tissue formation.Based on the information provided there is no indication or allegation that the device reported in this investigation contributed to the event and is therefore considered concomitant.The patient was revised from a size 6 triathlon baseplate and stem with a 6 x 9 mm ts insert to a size 5 triathlon baseplate and stem with a 5 x 9 mm ts insert.The stem was revised with a stem of the same catalog number: (5560-s-115).As the stem is assembled to the baseplate, the stem needs to be revised when the baseplate is to be revised.Thus, the stem is considered concomitant.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 CEMENTED STEM-15MM X 50MM
• 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: 11029250
• Report Number: 0002249697-2020-02689
• Device Sequence Number: 3548814
• Product Code: MBH
• UDI-Device Identifier: 07613327026702
• UDI-Public: 07613327026702
• 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: 2020
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/27/2021

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: 02/29/2024
• Device Model Number: 5560-S-115
• Device Catalogue Number: 5560-S-115
• Device Lot Number: 0084104M
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/24/2020
• Supplement Date Received by Manufacturer: 01/13/2021
• Initial Report FDA Received Date: 12/17/2020
• Supplement Report FDA Received Date: 01/27/2021
• 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: 59 YR