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

Catalog Number UNK_SHC

Device Problem Fracture (1260)

Patient Problem No Code Available (3191)

Event Date 11/06/2014

Event Type  Injury  

Event Description

It was reported at the 41st annual meeting of (b)(6) society.The tha or bha with centpillar gb stem was done.After this, revision surgery of stem was done because the circumference fracture of a stem.The 1 super secur-fit stem and 2 centpillar gb stems were reported in same report.This was 1/2 centpillar gb stems.

Manufacturer Narrative

Catalog number is unknown at this time.The device was reported as an unknown centpillar gb.Additional information has been requested and if received, will be provided in the supplemental report.Device not returned to manufacturer.

Manufacturer Narrative

An event regarding crack/fracture involving an unknown centpillar stem was reported.The event was not confirmed.Method & results: device evaluation and results: a visual, functional and dimensional inspection was not performed as the device was not returned.Medical records received and evaluation: insufficient information was received for review with a clinical consultant.Device history review could not be performed as the lot id is unknown.Complaint history review could not be performed as the lot id is unknown.Conclusions: the exact cause of the event could not be determined because insufficient information was provided.Further information such as return of device, operative reports, x-rays, patient history & follow-up notes are needed to investigate this event further.

Event Description

It was reported at the 41st annual meeting of (b)(6) hip society.The tha or bha with centpillar gb stem was done.After this, revision surgery of stem was done because the circumference fracture of a stem.The 1 super secur-fit stem and 2 centpillar gb stems were reported in same report.This was 1/2 centpillar gb stems.

• Brand Name: UNKNOWN_CORK_PRODUCT
• Type of Device: IMPLANT
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-CORK; ida industrial estate; carrigtwohill NA
• Manufacturer Contact: beverly lima ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 4295523
• MDR Text Key: 5269661
• Report Number: 0002249697-2014-04507
• Device Sequence Number: 1
• Product Code: MEH
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Literature
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/06/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/03/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK_SHC
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/19/2015
• 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