MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH NO 4. TRIATHLON TS PLUS TIBIAL INSERT X3 POLY 19MM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, C

Catalog Number	5537-G-419
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Unspecified Infection (1930); Injury (2348)
Date of Event	01/24/2013
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A review of the device history records indicates that the reported devices were manufactured and accepted into final stock with no reported discrepancies.The complaint history review indicated that there were no similar events for the reported lot.The following devices were also listed in this report: tri ts femur sz5 right; cat# 5512-f-502; lot# glog.Tri ts baseplate size 4; cat# 5521-b-400; lot# hosra.Tri press-fit stem 17mm x 100mm; cat# 5565-s-017; lot# m7h34h.Triathlon femoral distal augment 5mm - size 5 right; cat# 5540-a-502; lot# gzbv.Triathlon femoral distal augment 10mm - size 5 right; cat# 5541-a-502; lot# xdoh.Tri post augment sz5 10mm; cat# 5544-a-500; lot# hhek.Tri post augment sz5 5mm; cat# 5543-a-500; lot# glgl.Tri press-fit stem 14mm x 100mm; cat# 5565-s-014; lot# m6v07al.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.
Event or Problem Description
Postoperative diagnosis: patient had right knee replacement outside of cors scope.The patient underwent knee revision to treat the pain and dysfunction and mechanical problem on (b)(6) 2013.Then patient had infected prosthesis right knee and only the poly component was exchanged on (b)(6) 2013.

• Brand Name: NO 4. TRIATHLON TS PLUS TIBIAL INSERT X3 POLY 19MM
• Common Device Name: PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, C
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 8358829
• Report Number: 0002249697-2019-01132
• Device Sequence Number: 2284668
• Product Code: MBH
• UDI-Device Identifier: 07613327027259
• UDI-Public: 07613327027259
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K141056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2013
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/21/2019

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: 07/31/2016
• Device Catalogue Number: 5537-G-419
• Device Lot Number: MKKYDL
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/25/2019
• Initial Report FDA Received Date: 02/21/2019
• 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: Hospitalization; Required Intervention
• Patient Age: 68 YR
• Patient Weight: 91