MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-LIMERICK TRIATHLON P/A CR BEADED #5L; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number	5517F501
Medical Device Problem Code	Unstable (1667)
Health Effect - Clinical Code	Injury (2348)
Date of Event	10/03/2018
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.
Event or Problem Description
Instability, posterior sagging and wear of prosthesis approx.5 years after implantation.
Additional Manufacturer Narrative
Lot number of the device was corrected.An event regarding wear, instability & posterior sagging involving a triathlon femoral component 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: a review of the provided medical records by a clinical consultant stated the following comment: have seen the limited info for this patient with a triathlon revision because of instability.Posterior sag would indicate posterior cruciate ligament instability.The cause is however not evident from the info.The primary arthroplasty report has no indication for later trouble, surgery went uncomplicated with additional rsa bead implantation for investigation purposes.Component malposition is a frequent cause of the problem, alternatively inadequate initial liner thickness or pcl damage during primary arthroplasty.All would require x-rays for closer examination.With the current info, this case can unfortunately not be solved.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.Conclusion: the exact cause of the event could not be determined because insufficient information was provided.Additional information including x-rays and 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.
Event or Problem Description
Instability, posterior sagging and wear of prosthesis approx.5 years after implantation.

• Brand Name: TRIATHLON P/A CR BEADED #5L
• Common Device Name: PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-LIMERICK; raheen business park; limerick NJ NA
• MDR Report Key: 8046220
• Report Number: 0002249697-2018-03645
• Device Sequence Number: 1683883
• Product Code: MBH
• UDI-Device Identifier: 07613327040982
• UDI-Public: 07613327040982
• Combination Product (Y/N): N
• PMA/510(K) Number: K141056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/02/2019

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: 07/31/2017
• Device Catalogue Number: 5517F501
• Device Lot Number: EAJHT
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/10/2018
• Supplement Date Received by Manufacturer: 12/04/2018
• Initial Report FDA Received Date: 11/07/2018
• Supplement Report FDA Received Date: 01/02/2019
• 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: Other
• Patient Age: 59 YR
• Patient Weight: 89