MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH NO 5. TRIATHLON TS PLUS TIBIAL INSERT X3 POLY 22MM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Model Number	5537-G-522-E
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	04/30/2021
Type of Reportable Event	Serious Injury
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.Review of the device history records indicate devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.The following devices were also listed in this report: tri ts femur sz5 left; cat# 5512-f-501; lot# gv94v.Tri ts baseplate size 5; cat# 5521-b-500; lot# guy7ha.Tri post augment sz5 5mm; cat# 5543-a-500; lot# gao7h.Tri post augment sz5 5mm; cat# 5543-a-500; lot# eoz3d.Triathlon symmetric x3 patella; cat# 5550-g-360-e; lot# xjdp.Triathlon cemented stem-15mm x 50mm; cat# 5560-s-115; lot# 0104122j.Triathlon cemented stem-15mm x 50mm; cat# 5560-s-115; lot#.Cemented stem trial 12 x 50mm; cat# 5560-t-112; lot# unknown.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.Not returned.
Event or Problem Description
It was reported that a patient had a stage 1 revision competitor devices in their left knee on (b)(6) 2021.The implants used included triathlon stems in the tibia and femur.A stryker rep who is no longer with the company was present for the procedure.The second stage revision took place on (b)(6) 2021.During that revision, it was discovered that a 12x50 stem trial was found in the patient's tibial canal.Update per sales rep: patient had stryker parts implanted on (b)(6) 2021 (after removal of competitor parts).Patient then had a 2 stage revision due to infection, where a spacer was implanted approximately (b)(6) 2021.The 2nd stage occurred on (b)(6) 2021, where the spacer was removed and competitor parts were implanted.
Event or Problem Description
It was reported that a patient had a stage 1 revision competitor devices in their left knee on (b)(6) 2021.The implants used included triathlon stems in the tibia and femur.A stryker rep who is no longer with the company was present for the procedure.The second stage revision took place on (b)(6) 2021.During that revision, it was discovered that a 12x50 stem trial was found in the patient's tibial canal.Update per sales rep: patient had stryker parts implanted on (b)(6), 2021 (after removal of competitor parts).Patient then had a 2 stage revision due to infection, where a spacer was implanted approximately (b)(6), 2021.The 2nd stage occurred on (b)(6), 2021, where the spacer was removed and competitor parts were implanted.
Additional Manufacturer Narrative
An event regarding infection involving a triathlon insert was reported.The event was not confirmed.Method & results: -device evaluation and results: not performed as product was not returned -medical records received and evaluation: no medical records were received for review with a clinical consultant -device history review: all devices were manufactured and accepted into final stock with no relevant reported discrepancies.-complaint history review: there have been no other similar events for the reported lot or sterile lot.Conclusion: all stryker products sold as sterile are validated to a minimum sterility assurance level (sal) of 10^-6 in accordance to applicable iso standards.The exact cause of the event could not be determined because insufficient information was provided.  additional information including return of the device are needed to fully investigate the event.If further information becomes available or the product is returned, this investigation will be re-opened.   the following devices were also listed in this report: tri ts femur sz5 left; cat# 5512-f-501; lot# gv94v.Tri ts baseplate size 5; cat# 5521-b-500; lot# guy7ha.Tri post augment sz5 5mm; cat# 5543-a-500; lot# gao7h.Tri post augment sz5 5mm; cat# 5543-a-500; lot# eoz3d.Triathlon symmetric x3 patella; cat# 5550-g-360-e; lot# xjdp.Triathlon cemented stem-15mm x 50mm; cat# 5560-s-115; lot# 0104122j.Triathlon cemented stem-15mm x 50mm; cat# 5560-s-115.Cemented stem trial 12 x 50mm; cat# 5560-t-112; lot# unknown.Sm.Univ.Cement restrictor w/di; cat# b000-1185; lot# 6m9790.Sm.Univ.Cement restrictor w/di; cat# b000-1240; lot# 6m9905.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.

• Brand Name: NO 5. TRIATHLON TS PLUS TIBIAL INSERT X3 POLY 22MM
• 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: 12539834
• Report Number: 0002249697-2021-01633
• Device Sequence Number: 3990898
• Product Code: MBH
• UDI-Device Identifier: 07613327287936
• UDI-Public: 07613327287936
• Combination Product (Y/N): N
• Initial Reporter State: ME
• Initial Reporter Country: US
• PMA/510(K) Number: K172634
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/25/2021

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: 12/11/2024
• Device Model Number: 5537-G-522-E
• Device Catalogue Number: 5537-G-522-E
• Device Lot Number: H61HNW
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/30/2021
• Supplement Date Received by Manufacturer: 09/30/2021
• Initial Report FDA Received Date: 09/28/2021
• Supplement Report FDA Received Date: 10/25/2021
• 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: 76 YR