MAUDE Adverse Event Report: STRYKER ORTHOBIOLOGICS-MALVERN UNKNOWN_FRO_PRODUCT; IMPLANT

Catalog Number UNK_FRO

Device Problems Detachment Of Device Component (1104); Fitting Problem (2183)

Patient Problem Failure of Implant (1924)

Event Date 03/30/2017

Event Type  Injury  

Manufacturer Narrative

Device is not available for evaluation.If additional information is received it will be reported on a supplemental report.Device was discarded by the user facility.

Event Description

A sales representative stated that a medpor implant was removed due to a poor fit to the patient.Upon removal of the implant, the surgeon noted that the medpor plastic was becoming detached from the titanium.The patient had a revision surgery due to the alleged poor fit of the device.

• Brand Name: UNKNOWN_FRO_PRODUCT
• Type of Device: IMPLANT
• Manufacturer (Section D): STRYKER ORTHOBIOLOGICS-MALVERN; 45 great valley parkway; malvern PA 19355
• Manufacturer (Section G): STRYKER ORTHOBIOLOGICS-MALVERN; 45 great valley parkway; malvern PA 19355
• Manufacturer Contact: hans geiger ; boetzingerstr. 41; freiburg D-791-11 ; 76145120
• MDR Report Key: 6595311
• MDR Text Key: 76094472
• Report Number: 0008010177-2017-00116
• Device Sequence Number: 1
• Product Code: FTM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K040364
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK_FRO
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/03/2017
• 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