MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON P/A PS BEADED #3R; KNEE JOINT PATELLOFEMOROTIBIAL METAL/POLYMER POROUS-COATED UNCEMENTED PROSTHESIS

Catalog Number	5516F302
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/23/2018
Type of Reportable Event	Malfunction
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.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.Not returned.
Event or Problem Description
Mr.(b)(6) from the hospital reported to the ansm the following event: "transparent plastic container broken inside the carton (implant).Actions taken in the care facility for patient care: implant change.".
Event or Problem Description
Mr.(b)(6) from the hospital reported to the ansm the following event: "transparent plastic container broken inside the carton (implant).Actions taken in the care facility for patient care: implant change.".
Additional Manufacturer Narrative
An event regarding packaging damage involving a triathlon femoral component was reported.The event was confirmed based on review of the returned product.Method & results: device evaluation and results: on the unit carton, indentation lines are obvious on the sides and flap of the opening end on the inside and the outside.The outer blister was returned with the tyvek lid still attached on one lip of the flange.One corner of the plastic was broken off the outer blister and remains attached to the tyvek lid.There is evidence of a good seal on the outer blister.One side of the flange is cracked and lifting.The inner blister is sealed with the implant still inside, there is no evidence of damage to the inner blister.Medical records received and evaluation: not performed as the event is related to a packaging issue and no adverse consequences to the patient were reported.Device history review: indicated all devices were manufactured and accepted into final stock with no reported discrepancies.Complaint history review: there have been no other similar events for the lot referenced.Conclusions: on the unit carton, indentation lines are obvious on the sides and flap of the opening end on the inside and the outside.The outer blister was returned with the tyvek lid still attached on one lip of the flange.One corner of the plastic was broken off the outer blister and remains attached to the tyvek lid.There is evidence of a good seal on the outer blister.One side of the flange is cracked and lifting.The inner blister is sealed with the implant still inside, there is no evidence of damage to the inner blister the senior quality engineer-packaging dept.Completed an investigation into this event, the memo provided states the following "a complete review of manufacturing device history records have been completed for all the complaints received from france as referenced above.Nothing has been indicative of manufacturing related stress or a material issue with the packaging.No complaints have been received from any other customers in the field for the remaining devices in the batches.These appear to be isolated to the single customer and the single device in each case.The defect could not be replicated manually.Based on a review of this information, the manufacturing site cannot assume responsibility for the defects encountered." the exact cause of the event could not be determined to have been caused at the manufacturing site.A commonality is observed in these events that have all been reported for blister flange damage from the same hospital in france, a trend analysis will be completed under trend request to investigate this event further to determine a root cause.

• Brand Name: TRIATHLON P/A PS BEADED #3R
• Common Device Name: KNEE JOINT PATELLOFEMOROTIBIAL METAL/POLYMER POROUS-COATED UNCEMENTED PROSTHESIS
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 7669736
• Report Number: 0002249697-2018-02077
• Device Sequence Number: 805737
• Product Code: MBH
• UDI-Device Identifier: 07613327040791
• UDI-Public: 07613327040791
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K141056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 01/14/2019

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: 05/31/2022
• Device Catalogue Number: 5516F302
• Device Lot Number: B6L3L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/20/2018
• Initial Date Received by Manufacturer: 06/11/2018
• Supplement Date Received by Manufacturer: 12/17/2018
• Initial Report FDA Received Date: 07/09/2018
• Supplement Report FDA Received Date: 01/14/2019
• 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