MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH GMRS PROX FEM COM TROCHANTERIC; PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number	64951002
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/06/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Review of the device history records indicate devices were manufactured and accepted into final stock on with no relevant reported discrepancies.There have been no other events for the lot referenced.A supplemental report will be submitted upon completion of the investigation.
Event or Problem Description
It was reported that, during a surgery, when a nurse peeled a tyvek sheet, of the outer blister pack, sales staff found the crack on the outer blister pack, the inner blister had no damage so the surgeon decided to use the component as is.
Additional Manufacturer Narrative
Additional information: device evaluated by mfg; an event regarding packaging damage involving a gmrs femoral component was reported.The event was confirmed by visual inspection.Method & results: -device evaluation and results: an outer blister was returned in a cardboard box.No unit carton or inner blister was returned.The tyvek lid was partially removed from the outer blister.There is evidence of a good seal on the blister.One side flange/lip of the outer blister was broken/cracked but remains attached to the blister.-medical records received and evaluation: not performed as no medical records were provided for review.-device history review: indicate 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 lot referenced.Conclusions: the exact cause of the event could not be determined as insufficient information was provided.Further information such as all packaging is required to complete the investigation for determining a root cause.It must be noted that the inner blister had no damage so the surgeon decided to use the component as is.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
It was reported that, during a surgery, when a nurse peeled a tyvek sheet, of the outer blister pack, sales staff found the crack on the outer blister pack, the inner blister had no damage so the surgeon decided to use the component as is.

• Brand Name: GMRS PROX FEM COM TROCHANTERIC
• Common Device Name: PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 7081372
• Report Number: 0002249697-2017-03468
• Device Sequence Number: 19027927
• Product Code: KRO
• UDI-Device Identifier: 07613327048711
• UDI-Public: 07613327048711
• Combination Product (Y/N): N
• PMA/510(K) Number: K023087
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/25/2018

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: 04/14/2022
• Device Catalogue Number: 64951002
• Device Lot Number: B6N9T
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/15/2017
• Initial Date Received by Manufacturer: 11/06/2017
• Supplement Date Received by Manufacturer: 01/03/2018
• Initial Report FDA Received Date: 12/04/2017
• Supplement Report FDA Received Date: 01/25/2018
• 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