MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH MRS FEM STEM W/O BODY 17X127MM; PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number	64853117
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/29/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Review of the product history records indicate devices were manufactured and accepted into final stock 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
Primary procedure, proximal femur.As reported: "we opened the implant box, surgical tech peeled back the protective packaging and she and the surgeon noticed white specs.On the implant immediately upon opening.The surgeon then asked for a new implant to be opened.The per implant never was removed from the [inner sterile tray], never was implanted, and never touched the patient".Rep reported there was no surgical delay in providing a second implant.Rep was present for the procedure.None of the packaging except the inner sterile tray was retained.
Event or Problem Description
Primary procedure, proximal femur.As reported: "we opened the implant box, surgical tech peeled back the protective packaging and she and the surgeon noticed white specs.On the implant immediately upon opening.The surgeon then asked for a new implant to be opened.The per implant never was removed from the [inner sterile tray], never was implanted, and never touched the patient".Rep reported there was no surgical delay in providing a second implant.Rep was present for the procedure.None of the packaging except the inner sterile tray was retained.
Additional Manufacturer Narrative
Reported event: an event regarding foreign matter on an implant and within its inner sterile pack involving an mrs stem was reported.The reported event was confirmed by visual inspection of photographs provided.Method & results: device evaluation and results: visual inspection of the returned mrs stem indicates that there is no foreign matter on the component.The packaging for the component was not returned for evaluation.Photographs of the product and packaging were provided by the customer which confirms four or five small white shards of debris/foreign matter on the mrs stem.Medical records received and evaluation: not performed as the event is related to a packaging issue and the reported device was not implanted.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: visual inspection of the returned mrs stem indicates that there is no foreign matter on the component.The packaging for the component was not returned for evaluation.Photographs of the product and packaging were provided by the customer which confirms four or five small white shards of debris/foreign matter on the mrs stem.It is not possible to determine the root cause of the reported white specs as the packaging and samples of the white specs were not returned to stryker for evaluation.Return of the product packaging and the reported foreign matter would be required to investigate this event further to determine the root cause.No further investigation for this event is required at this time.

• Brand Name: MRS FEM STEM W/O BODY 17X127MM
• 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: 7911788
• Report Number: 0002249697-2018-03075
• Device Sequence Number: 13883729
• Product Code: KRO
• UDI-Device Identifier: 07613327048384
• UDI-Public: 07613327048384
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K040749
• 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): 02/07/2019

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: No Information
• Device Expiration Date: 06/30/2022
• Device Catalogue Number: 64853117
• Device Lot Number: 170520C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/11/2018
• Initial Date Received by Manufacturer: 08/29/2018
• Supplement Date Received by Manufacturer: 01/11/2019
• Initial Report FDA Received Date: 09/26/2018
• Supplement Report FDA Received Date: 02/07/2019
• 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: 47 YR