MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON CR FEM COMP #6 L-CEM; KNEE JOINT PATELLOFEMOROTIBIAL POLYMER/METAL/POLYMER SEMI-CONSTRAINED CEMENTED P

Catalog Number	5510F601
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/18/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A supplemental report will be submitted upon completion of the investigation.
Event or Problem Description
As reported: "opened fully sealed box and outer plastic shell was broken.Box seems to be intact but does have wrinkles where it may have been squeezed or under pressure in transit?" rep provided pictures of the packaging for a size 6 left cr cemented femoral component with one side of the outer blister's plastic tray broken off the tray and adhered to the tyvek.
Event or Problem Description
As reported: "opened fully sealed box and outer plastic shell was broken.Box seems to be intact but does have wrinkles where it may have been squeezed or under pressure in transit?" rep provided pictures of the packaging for a size 6 left cr cemented femoral component with one side of the outer blister's plastic tray broken off the tray and adhered to the tyvek.
Additional Manufacturer Narrative
An event regarding pack damage involving a triathlon femoral component was reported.The event was confirmed by visual inspection of the returned product.Method & results: device evaluation and results: one unit carton without its shrink wrap was returned for evaluation.Compression and indentation lines are visible on both ends of the unit carton.Compression is also visible on one side and bottom corner of the unit carton.The outer blister was returned with the tyvek lid removed.One side flange is broken away from the outer blister.The broken section of the flange remains attached to the tyvek lid.There is evidence of a good seal on the three remaining sides of the outer blister.The inner blister with its tyvek lid attached was returned with inside the outer blister.For the purpose of this investigation the tyvek lid was removed from the inner blister.There is evidence of a good seal on all four sides of the inner blister.The femoral component appears unremarkable.Clinician review: no medical records were received for review with a clinical consultant.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.Conclusion: based on the visual inspection of the returned product the investigation concluded that the packaging damage was most likely caused by incorrect/excessive handling prior to opening of the product whereby the unit carton may have been compressed and/or dropped from a height causing the damage to the carton.No further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.

• Brand Name: TRIATHLON CR FEM COMP #6 L-CEM
• Common Device Name: KNEE JOINT PATELLOFEMOROTIBIAL POLYMER/METAL/POLYMER SEMI-CONSTRAINED CEMENTED P
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 8249543
• Report Number: 0002249697-2019-00194
• Device Sequence Number: 1439245
• Product Code: JWH
• UDI-Device Identifier: 07613327040319
• UDI-Public: 07613327040319
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/15/2019

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: 07/30/2023
• Device Catalogue Number: 5510F601
• Device Lot Number: D4R2T
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/09/2019
• Initial Date Received by Manufacturer: 12/18/2018
• Supplement Date Received by Manufacturer: 02/15/2019
• Initial Report FDA Received Date: 01/15/2019
• Supplement Report FDA Received Date: 03/15/2019
• 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: 60 YR