MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH NO 4. TRIATHLON TS PLUS TIBIAL INSERT X3 POLY 13MM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number	5537-G-413
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Pain (1994)
Date of Event	06/20/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The following devices were also listed in this report: tri ts baseplate size 4; cat#5521-b-400; lot#frd, triathlon total knee system offset adapter 6mm; cat#5570-s-060; lot#m3w40am, tri press-fit stem 16mm x 100mm; cat#5565-s-016; lot#m6s43j, triathlon total knee system offset adapter 4mm; cat#5570-s-040; lot#m6m13a, triathlon femoral distal augment 5mm - size 4 left; cat#5540-a-401; lot#dzjr, tri press-fit stem 15mm x 100mm; cat#5565-s-015; lot#m4c20e, triathlon femoral distal augment 5mm - size 4 left; cat#5540-a-401; lot#duxj, tri ts femur sz4 left; cat#5512-f-401; lot#edil.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.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 information in this report was provided by stryker orthopaedics legal affairs department.No additional information is available at this time due to the ongoing litigation.Should additional information become available, the evaluation summary will be submitted in a supplemental report.
Event or Problem Description
Based on the medical review in pi 2038833, it was reported that at 1-year post second revision, on (b)(6) 2014, patient complained about severe left knee pain, vas 10/10 scale, with limping of the knee requiring a cane for walking support.On (b)(6) 2016 knee pain was still reported as persistent but no knee rom or flexion was documented in the records.Patient was last seen on (b)(6) 2018, with still persistent knee symptoms although no details about pain level or knee rom were documented in the (otherwise plentiful) records.An mri of the left knee was made on (b)(6) 2018, but did not show any device pathology as far as evident from the pictures with obvious device deformation despite use of mars mri (metal artefact removal software mri).

• Brand Name: NO 4. 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: 9361744
• Report Number: 0002249697-2019-03846
• Device Sequence Number: 2972831
• Product Code: MBH
• UDI-Device Identifier: 07613327027242
• UDI-Public: 07613327027242
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/22/2019

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: 02/28/2016
• Device Catalogue Number: 5537-G-413
• Device Lot Number: MKD6PY
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/25/2019
• Initial Report FDA Received Date: 11/22/2019
• 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: Other
• Patient Age: 65 YR