MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON PS FEM COMP #7R-CEM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, C

Catalog Number	5515F702
Medical Device Problem Code	Unstable (1667)
Health Effect - Clinical Code	Injury (2348)
Date of Event	03/05/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was noted that the device is not available for evaluation.A review of the device history records indicate that devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.Device not available.
Event or Problem Description
It was reported that the patient's right knee was revised after patient presented with a complaint in (b)(6) 2018 (nature of the complaint not reported to rep).Intra-operatively, the tip of the device was broken off and one side was worn.Update per revision operative report: "mechanical compromise of right total knee arthroplasty with associated flexion instability (ply wear of tibial poly insert) plus fracture of tibial poly insert post.Revision total knee arthroplasty (tibial poly exchange) with removal of loose body, lysis of adhesions, and partial synovectomy.".
Additional Manufacturer Narrative
An event regarding crack/fracture involving triathlon insert was reported.Conclusion: 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.There is no allegation of failure against the femoral component which was not revised during this procedure.Instability was reported but this can likely be attributed to the fracture of the tibial post of the triathlon tibial insert.No further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
It was reported that the patient's right knee was revised after patient presented with a complaint in (b)(6) 2018 (nature of the complaint not reported to rep).Intra- operatively, the tip of the device was broken off and one side was worn.Update per revision operative report: "mechanical compromise of right total knee arthroplasty with associated flexion instability (ply wear of tibial poly insert) plus fracture of tibial poly insert post.Revision total knee arthroplasty (tibial poly exchange) with removal of loose body, lysis of adhesions, and partial synovectomy.".

• Brand Name: TRIATHLON PS FEM COMP #7R-CEM
• 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: 8666694
• Report Number: 0002249697-2019-02160
• Device Sequence Number: 2257744
• Product Code: MBH
• UDI-Device Identifier: 07613327040739
• UDI-Public: 07613327040739
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: K141056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/27/2019

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: 09/30/2014
• Device Catalogue Number: 5515F702
• Device Lot Number: XTFT
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/07/2019
• Supplement Date Received by Manufacturer: 05/31/2019
• Initial Report FDA Received Date: 06/04/2019
• Supplement Report FDA Received Date: 06/27/2019
• 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: 116