MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH GMRS DIST FEM COMP STD R 65MM; PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number	64952040
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/08/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Reported event: an event regarding packaging damage involving a gmrs distal femoral component was reported.The event was confirmed by visual inspection.Method & results: device evaluation and results: one unit carton complete with shrink wrap was returned for evaluation.The shrink wrap was opened on one end and has a loaner label on it.Indentation lines and compression lines are visible on the unit carton especially around the opening end of the unit carton.The outer blister appears damaged.Two side flanges are broken off the outer blister.The broken section of the flanges remain attached to the tyvek lid.The inner blister was returned inside the outer blister.The opening corner of the inner blister is opened.There is evidence of the tyvek seal having been applied, however on the outer and inner blister are no longer sterile barriers due to the damaged flanges.Medical records received and evaluation: not performed as the event is related to a packaging issue.Device history review: indicated all devices were manufactured and accepted into final stock on with no reported discrepancies.Complaint history review: there have been no other events for the lot referenced.Conclusion: one unit carton complete with shrink wrap was returned for evaluation.The shrink wrap was opened on one end and has a loaner label on it.Indentation lines and compression lines are visible on the unit carton especially around the opening end of the unit carton indicative of multiple opening/closing operations.The outer blister appears damaged.Two side flanges are broken off the outer blister.The broken section of the flanges remain attached to the tyvek lid.The inner blister was returned inside the outer blister.The opening corner of the inner blister is opened.There is evidence of the tyvek seal having been applied, however on the outer and inner blister are no longer sterile barriers due to the damaged flanges.It is noted that due to sterility concerns, the surgeon elected to re-implant the explanted components as no better alternatives were at hand.This is considered to be an off label application.The investigation concluded that the packaging damage was most likely caused by excessive/incorrect handling prior to the surgery.No further investigation for this event 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
This pi is for the intra-operative event on (b)(6) 2018.It was reported that during revision of patient's right knee, the outer rim of the outer blister was attached to the tyvek as the implant was opened.A corner of the inner blister was not adhered to the tray.Due to sterility concerns, the surgeon elected to re-implant the explanted components as no better alternatives were at hand.

• Brand Name: GMRS DIST FEM COMP STD R 65MM
• 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: 8039223
• Report Number: 0002249697-2018-03602
• Device Sequence Number: 11128683
• Product Code: KRO
• UDI-Device Identifier: 07613327048780
• UDI-Public: 07613327048780
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K023087
• 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
• Report Date (Section B): 11/05/2018

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: 12/31/2022
• Device Catalogue Number: 64952040
• Device Lot Number: C443Y
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/16/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/08/2018
• Initial Report FDA Received Date: 11/05/2018
• 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
• Patient Age: 61 YR