MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH MRS SML FEM STEM 8 X 102MM; IMPLANT

Catalog Number 64853008

Device Problems Loss of or Failure to Bond (1068); Break (1069)

Patient Problem Unspecified Infection (1930)

Event Date 02/25/2014

Event Type  Injury  

Manufacturer Narrative

Additional information has been requested and if received will be submitted in a follow up report upon completion of the investigation.Not returned.

Manufacturer Narrative

The patient is (b)(6) in height.An event regarding stem fracture involving an mrs stem was reported.The event was not confirmed.Device evaluation was not possible as the component was not returned.No medical information was provided for this investigation.Evaluation of the explanted device, x-rays, patient history, operative reports and progress notes would be required to determine a root cause for this event.

Event Description

It was reported that the patients' right knee was revised due to breakage of gmrs stem.The patient had an infection and the surgeon commented that the cement had debonded which added load bearing on stem.

Event Description

It was reported that the patient's right knee was revised due to breakage of gmrs stem.The patient had an infection and the surgeon commented that the cement had debonded which added load bearing on stem.

• Brand Name: MRS SML FEM STEM 8 X 102MM
• Type of Device: IMPLANT
• 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: beverly lima ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 3691900
• MDR Text Key: 18767332
• Report Number: 0002249697-2014-00836
• Device Sequence Number: 1
• Product Code: KRO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K040749
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/25/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 64853008
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/22/2014
• 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
• Patient Age: 28 YR
• Patient Weight: 74