MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRITANIUM BPLATE TRIATHLON S5; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	5536B500
Medical Device Problem Codes	Loss of Osseointegration (2408); Malposition of Device (2616)
Health Effect - Clinical Codes	Injury (2348); Ambulation or Postural Difficulties (2544); Inadequate Osseointegration (2646)
Date of Event	05/22/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Review of the device history records indicates devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.It was noted that the device is not available for evaluation.Additional information has been requested.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.
Event or Problem Description
Company representative reported patient had left knee revision due to relative loosening of tibial component with varus alignment and lateral component liftoff.
Additional Manufacturer Narrative
An event regarding loosening of the tritanium baseplate was reported.The event was confirmed through medical review.Method & results: device evaluation and results: not performed as no product was returned for analysis.Medical records received and evaluation: the principal problem is component malposition, especially the baseplate.The primary arthroplasty surgical report does not reference any problems and as such it is not clear what the cause for these problems has been.The primary knee had complex problems with severe valgus deformity and probably also instability prior to arthroplasty but the implanted triathlon ps devices should be perfectly capable of restoring adequate functionality and stability of the knee if implanted in adequate size and position.Because the surgeon is responsible for optimal component position and the indication for surgery was component malposition with knee malalignment, principle failure mode is procedure - related.Device history review: indicate all devices were manufactured and accepted into final stock on with no reported discrepancies.Complaint history review: there have been no other events for the lot referenced.Conclusion: the medical review indicated that: tibial baseplate malposition in varus deformity with lateral lift-off and consequent loss of implant-bone contact has contributed to lack of bone ingrowth resulting in baseplate loosening requiring revision.A capa trend analysis was conducted for the reported failure mode and concluded tritanium baseplate loosening may result from factors not related to the device.No further investigation is possible at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
Company representative reported patient had left knee revision due to relative loosening of tibial component with varus alignment and lateral component liftoff.

• Brand Name: TRITANIUM BPLATE TRIATHLON S5
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 6698772
• Report Number: 0002249697-2017-02148
• Device Sequence Number: 880725
• Product Code: MBH
• UDI-Device Identifier: 07613327041507
• UDI-Public: 07613327041507
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K141056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/29/2017

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: 01/11/2022
• Device Catalogue Number: 5536B500
• Device Lot Number: CTD13528
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/12/2017
• Supplement Date Received by Manufacturer: 08/31/2017
• Initial Report FDA Received Date: 07/10/2017
• Supplement Report FDA Received Date: 09/29/2017
• 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: 77 YR