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

Model Number	5551-G-401
Medical Device Problem Codes	Degraded (1153); Naturally Worn (2988)
Health Effect - Clinical Code	Pain (1994)
Date of Event	11/09/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Triathlon ts femoral revision patient had complained of worsening pain.Previous tibial revision in 2019 implant details available for that surgery.During surgery was noted the patella had wear marks this was also replaced.
Additional Manufacturer Narrative
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 stem extender; cat# 5571s025; lot# v30elp.Tri ts baseplate size 4; cat# 5521b400; lot# doe7za.Med howmedica bone plug 1pk; cat# 62155011; lot# cppuj06bf.Tri cemented stem 12mmx50mm; cat# 5560s112; lot# 0087225h.No 4.Triathlon ts plus tibial insert x3 poly 16mm; cat# 5537g416; lot# 7857py.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.Not returned.
Additional Manufacturer Narrative
Corrected data: date of implant.An event regarding wear involving a triathlon patella was reported.The event was confirmed via evaluation of the returned device.Method & results: product evaluation and results: visual inspection: visual inspection of the returned device indicated that the patella is worn.The damage present on the anterior and posterior surfaces is consistent with delamination and material loss.The damage on the articulating surface of the patella is consistent with burnishing, scratching, and third body indentations; which are common damage modes of uhmwpe.Clinician review: no medical records relevant to this event were received for review with a clinical consultant.Product history review: could not be performed as the device lot details were not provided.Complaint history review: could not be performed as the device lot details were not provided.Conclusions: it was reported that the patient was revised due to pain and wear of the patella was observed intraoperatively.Visual inspection of the returned device indicated that the patella is worn.The damage present on the anterior and posterior surfaces is consistent with delamination and material loss.The damage on the articulating surface of the patella is consistent with burnishing, scratching, and third body indentations; which are common damage modes of uhmwpe.No further investigation for this event is possible at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.The following devices were also listed in this report: triathlon stem extender; cat# 5571s025; lot# v30elp.Tri ts baseplate size 4; cat# 5521b400; lot# doe7za.Med howmedica bone plug 1pk; cat# 62155011; lot# cppuj06bf.Tri cemented stem 12mmx50mm; cat# 5560s112; lot# 0087225h.No 4.Triathlon ts plus tibial insert x3 poly 16mm; cat# 5537g416; lot# 7857py.Tri ts femur sz5 left; cat# 5512-f-501; lot# hvjo.Tri press-fit stem 12mm x 100mm; cat# 5565-s-012; lot# m6n19.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.
Event or Problem Description
Triathlon ts femoral revision patient had complained of worsening pain.Previous tibial revision in 2019 implant details available for that surgery.During surgery was noted the patella had wear marks this was also replaced.

• Brand Name: TRIATHLON ASYMMETRIC X3 PATELLA
• Common Device Name: PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer Contact: brad curtis ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 15922671
• Report Number: 0002249697-2022-01773
• Device Sequence Number: 15128198
• Product Code: MBH
• UDI-Device Identifier: 07613327014839
• UDI-Public: 07613327014839
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K141056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/13/2023

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 Model Number: 5551-G-401
• Device Catalogue Number: 5551-G-401
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/09/2022
• Supplement Date Received by Manufacturer: 02/18/2023
• Initial Report FDA Received Date: 12/06/2022
• Supplement Report FDA Received Date: 03/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 71 YR
• Patient Sex: Male