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

Catalog Number	5510F701
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/15/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A supplemental report will be submitted upon completion of the investigation.Review of the device history records indicate devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.
Event or Problem Description
The customer reported that when they opened the device there was damage discovered to the inner plastic packaging of a triathlon femoral implant during a tkr.The customer further reported that the rim of the plastic box isn¿t complete all the way around.This piece of plastic that has snapped off is actually stuck to the back of the peel cover.**update** the customer reported that every other aspect of the packaging was intact.A replacement was used to complete the case.As reported in the attached stryker complaint intake form "this product was not introduced into the procedure/taken into the sterile field by the surgeon.Another one of the consignment stock was opened, this did not have any defects/issues, and the procedure was completed as normal".Procedure was confirmed as a primary procedure.
Additional Manufacturer Narrative
An event regarding pack damage involving a triathlon femoral component was reported.The event was confirmed through evaluation of the returned product.Method & results -product evaluation and results: the unit carton and outer blister were returned for evaluation.The unit carton is partially wrapped in shrink wrap.Indentation lines and compression are visible on the unit carton.The tyvek lid was removed from the outer blister.One side flange is broken/cracked away from the outer blister.The broken section remains attached to the tyvek lid.-medical records received and evaluation: no medical records were received for review with a clinical consultant.-product history review: a review of the device manufacturing records indicate that all devices accepted into final stock were free from discrepancies.-complaint history review: there have been no other similar events for the lot referenced.Conclusions: the reported device including packaging was returned for evaluation.The unit carton and outer blister were returned for evaluation.The unit carton is partially wrapped in shrink wrap.Indentation lines and compression are visible on the unit carton.The tyvek lid was removed from the outer blister.One side flange is broken/cracked away from the outer blister.The broken section remains attached to the tyvek lid.The investigation concluded that the packaging damage was most likely caused by excessive/incorrect handling prior to the opening packaging whereby the carton may have been compressed and/or dropped from a height causing the damage to the carton.No further investigation for this event is required at this time.
Event or Problem Description
The customer reported that when they opened the device there was damage discovered to the inner plastic packaging of a triathlon femoral implant during a tkr.The customer further reported that the rim of the plastic box isn¿t complete all the way around.This piece of plastic that has snapped off is actually stuck to the back of the peel cover.**update** the customer reported that every other aspect of the packaging was intact.A replacement was used to complete the case.As reported in the attached stryker complaint intake form "this product was not introduced into the procedure/taken into the sterile field by the surgeon.Another one of the consignment stock was opened, this did not have any defects/issues, and the procedure was completed as normal".Procedure was confirmed as a primary procedure.

• Brand Name: TRIATHLON CR FEM COMP #7 L-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: 9006285
• Report Number: 0002249697-2019-03187
• Device Sequence Number: 11507408
• Product Code: MBH
• UDI-Device Identifier: 07613327040333
• UDI-Public: 07613327040333
• Combination Product (Y/N): N
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/24/2019

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: 02/28/2023
• Device Catalogue Number: 5510F701
• Device Lot Number: DHT2J
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/28/2019
• Initial Date Received by Manufacturer: 08/16/2019
• Supplement Date Received by Manufacturer: 09/27/2019
• Initial Report FDA Received Date: 09/12/2019
• Supplement Report FDA Received Date: 10/24/2019
• 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