MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH AVON PAT/FEM JOINT EX SMALL; IMPLANT

Catalog Number 64300050

Device Problem Insufficient Information (3190)

Patient Problem Pain (1994)

Event Date 06/23/2014

Event Type  Injury  

Event Description

It was reported that patella femoral implants were revised due to pain.

Manufacturer Narrative

Additional devices listed in this report: cat 5550-g-278, patella 27mm, lot code 883k; cat 6197-9-001, simplex p with tobramycin 1 pack, lot code mdq021.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.Additional information has been requested and if received, will be provided in the supplemental report.

Manufacturer Narrative

The patient is (b)(6) in height.An event regarding revision of an avon femur due to wear of the femoral condyles was reported.The event was confirmed.Device evaluation and results: visual inspection indicated the joint indicated no notable signs of wear or damage.Medical records received and evaluation: a review of the provided medical records by a clinical consultant indicated: no clinical or past medical history, no operative reports, and no description of the duration, nature or severity of the pain indicating the revision surgery are available.The material analysis report appears to have ruled out factors of faulty manufacturing or materials as being responsible for this clinical situation.Device history review: all devices accepted into final stock met specification.Complaint history review: there have been no other events for the reported lot.Conclusions: the investigation concluded the pain and revision of the avon femur was due to increased wear of the femoral condyles, i.E.Disease progression.Analysis of the returned component indicated there was no material or manufacturing defects were observed on the device features evaluated.

Event Description

Per email update dated 07-jul-2014: surgeon noted ware on the patella but no mechanical failure.Surgeon indicated that the pain was cause by new ware on the femoral condyles which led to a total joint replacement.".

• Brand Name: AVON PAT/FEM JOINT EX SMALL
• 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: 3936187
• MDR Text Key: 19404884
• Report Number: 0002249697-2014-02718
• Device Sequence Number: 1
• Product Code: NPJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K052917
• 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: 06/24/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2014
• Device Catalogue Number: 64300050
• Device Lot Number: SLK3S
• Other Device ID Number: STERILE LOT K1123
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/28/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/20/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/27/2009
• 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: 32 YR
• Patient Weight: 102