MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH PROXIMAL FEM COMP STD; PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number 64951001

Device Problem Device Packaging Compromised (2916)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/13/2017

Event Type  malfunction  

Manufacturer Narrative

Review of the device history records indicate the devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.A supplemental report will be submitted upon completion of the investigation.

Event Description

It was reported that while performing a procedure on patient's knee (side not reported), implant appeared to have been repackaged.The outer seal was compromised.Upon inspection of the inner seal, it was found to have been compromised.The surgeon refused use of the implant due to sterility concerns.An alternative implant was available in approximately 2 minutes.The procedure was completed successfully otherwise.

Manufacturer Narrative

Device not returned.Product available to stryker.An event regarding packaging damage involving a gmrs femoral component was reported.The event was not confirmed.Device evaluation and results: not performed as no product was returned for evaluation.Medical records received and evaluation: not performed as the event is related to a packaging issue.Indicated all devices were manufactured and accepted into final stock on with no reported discrepancies.There have been no other similar events for the lot referenced.As no product was returned or no photographs provided the reported event could not be confirmed.Further information such as all packaging return including the outer blister and unit carton is required to complete the investigation for determining a root cause.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 Description

It was reported that while performing a procedure on patient's knee (side not reported), implant appeared to have been repackaged.The outer seal was compromised.Upon inspection of the inner seal, it was found to have been compromised.The surgeon refused use of the implant due to sterility concerns.An alternative implant was available in approximately 2 minutes.The procedure was completed successfully otherwise.

• Brand Name: PROXIMAL FEM COMP STD
• Type of Device: PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-LIMERICK; raheen business park; limerick NA
• Manufacturer Contact: brian lauro ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6943088
• MDR Text Key: 90161783
• Report Number: 0002249697-2017-02978
• Device Sequence Number: 1
• Product Code: KRO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K023087
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2020
• Device Catalogue Number: 64951001
• Device Lot Number: EL8LP
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/02/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 59 YR