MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN_RECONSTRUCTIVE_PRODUCT; IMPLANT

Catalog Number UNK_REC

Device Problems Device Slipped (1584); Material Integrity Problem (2978)

Patient Problem Pain (1994)

Event Date 01/07/2014

Event Type  Injury  

Event Description

It was reported that the patient was complaining of pain the implants were loose, poly wear.

Manufacturer Narrative

Catalogue number unknown at this time.Device description reported as unknown duracon femur.A supplemental report will be submitted upon completion of the investigation.

Manufacturer Narrative

No device evaluation, history review or complaint history was performed as no devices were received or identified.No patient medical records were available for review.The event could not be confirmed nor the root cause determined because the devices were not returned for evaluation and insufficient medical information was provided.The exact cause of the event could not be determined because the reported event could not be confirmed.The reported event regarding loosening involving an unknown duracon femoral component was not confirmed.

Event Description

It was reported that the patient was complaining of pain the implants were loose, poly wear.

• Brand Name: UNKNOWN_RECONSTRUCTIVE_PRODUCT
• Type of Device: 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: william hanna ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 3599408
• MDR Text Key: 20006778
• Report Number: 0002249697-2014-00222
• Device Sequence Number: 1
• Product Code: LWJ
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 01/07/2014

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?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/09/2014
• Initial Date FDA Received: 01/30/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/25/2014
• Was Device Evaluated by Manufacturer?: No
• 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: 80 YR
• Patient Weight: 69