MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN PKR POLYETHYLENE; KNEE IMPLANT

Catalog Number UNK_REC

Device Problems Material Discolored (1170); Insufficient Information (3190)

Patient Problem No Information (3190)

Event Date 02/01/2016

Event Type  Injury  

Manufacturer Narrative

The following other device was also listed in this report: unknown baseplate; cat# unknown; lot# unknown.Unknown femoral; cat# unknown; lot# unknown.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.An evaluation of the device cannot be performed as the device was not returned to the manufacturer.Additional information has been requested.Should additional information become available it will be reported in a supplemental report upon completion of the investigation.

Event Description

It has been reported by the distributor that a pkr knee prosthesis that was implanted 9 months ago.The reason for the anticipated revision surgery is to be determined.When the surgeon explanted the polyethylene noticed that it had a yellowish colour by both faces.The surgeon replaced the pkr by a complex primary triathlon prosthesis.

Manufacturer Narrative

Corrected data: the device was not returned for evaluation.An event regarding the discoloration of an unknown insert which was explanted for unspecified reasons was reported.The event was confirmed by photographs.Method & results: device evaluation and results: the device was not returned however two photographs of the insert were provided.The superior surface of the insert has some discoloration which is indicative of absorption of synovial fluid.The device otherwise appears unremarkable for a device that was implanted.Conclusion: review of the photographs provided indicate that the yellow discoloration is that of absorption of synovial fluid and is as such a common aspect regarding implanted inserts.The exact cause of the unspecified revision of the insert could not be determined because insufficient information was provided.Further information such as product details, product return, pre- and post-operative x-rays, operative reports as well as patient history and follow-up notes are needed to complete the investigation for determining a root cause.No further investigation is possible at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.

Event Description

It has been reported by the distributor that a pkr knee prosthesis was implanted 9 months ago.The reason for the anticipated revision surgery is to be determined.When the surgeon explanted the polyethylene noticed that it had a yellowish colour by both faces.The surgeon replaced the pkr by a complex primary triathlon prosthesis.

• Brand Name: UNKNOWN PKR POLYETHYLENE
• Type of Device: KNEE IMPLANT
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer Contact: keyla colon ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 5467598
• MDR Text Key: 39274014
• Report Number: 0002249697-2016-00608
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• Reporter Country Code: ES
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/03/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK_REC
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/03/2016
• Initial Date FDA Received: 02/29/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/27/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Required Intervention