MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON CR X3 TIBIAL INSERT; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	5530-G-609
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	01/26/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was noted that the device is not available for evaluation.Additional information has been requested and if received, will be provided in the supplemental report upon completion of the investigation.
Event or Problem Description
Insert would not lock into baseplate after repeated tries.
Additional Manufacturer Narrative
Corrected data: the device was returned an event regarding a seating/locking issue involving a triathlon insert was reported.The event was not confirmed.Method & results: device evaluation and results: the insert was returned without the locking wire.The device shows some scratches and explantation damages on the anterior side and it was fractured from posterior side.Further "examination of the returned device with material analysis engineer indicated explanation damage noted.Locking wire not returned." -medical records received and evaluation: not performed as the reported component was not implanted.-device history review: device history review indicated the devices accepted into final stock from the reported lot were free from discrepancies -complaint history review: there has been no other event for the lot referenced.Conclusions: the event could not be confirmed nor the root cause determined because insufficient information was provided.The reported event describes an issue with an insert while attempting to seat the insert on the baseplate.Based on the visual inspection of the returned component it is concluded that the device shows some scratches and explantation damages on the anterior side and it was fractured from posterior side.Further consultation of the returned device with material analysis engineer indicated explanation damage noted.Locking wire not returned.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
Insert would not lock into baseplate after repeated tries.

• Brand Name: TRIATHLON CR X3 TIBIAL INSERT
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 6356921
• Report Number: 0002249697-2017-00659
• Device Sequence Number: 16153837
• Product Code: JWH
• UDI-Device Identifier: 07613327050585
• UDI-Public: (01)07613327050585(11)161221(17)211231(10)M305L7
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K051146
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2021
• Device Catalogue Number: 5530-G-609
• Device Lot Number: M305L7
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/10/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 01/26/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/24/2017
• Supplement Report FDA Received Date: 04/26/2017
• 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: Other
• Patient Age: 64 YR