MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH RESTORATION ADM X3 INS 28/48; IMPLANT

Catalog Number 1236-2-848

Device Problems Device Dislodged or Dislocated (2923); Scratched Material (3020)

Patient Problem No Code Available (3191)

Event Date 03/18/2014

Event Type  Injury  

Event Description

The patient was done right tha at (b)(6) 2014.The revision surgery with v40 head was done at (b)(6) 2014, because a cup and a head were dislocated.When the revision surgery, scratch was confirmed at the neck of the stem.

Manufacturer Narrative

A review of the photographs provided confirmed that the head dislocated from the adm poly insert, not the cup as was originally stated.The reporter indicated that the head was the only device explanted.Should additional information become available, it will be provided in the supplemental report upon completion of the investigation.Remains implanted.

Manufacturer Narrative

An event regarding dislocation involving an adm liner was reported.The event was not confirmed.The device was not available for evaluation.Medical records received and provided x-rays were deemed insufficient for a medical review by a clinical consultant.Operative notes, clinical history, medical records and examination of the components are needed for further evaluation.Device history review.The reported device was accepted into final stock with no reported discrepancies.Complaint history review.There have been no other events for the reported lot.The exact cause of the event could not be determined as the devices, operative notes, clinical history and medical records are needed for further evaluation.No further investigation for this event is possible at this time.

Event Description

The patient was done right tha at (b)(6) 2014.The revision surgery with v40 head was done at (b)(6) 2014, because a cup and a head were dislocated.When the revision surgery, scratch was confirmed at the neck of the stem.

• Brand Name: RESTORATION ADM X3 INS 28/48
• 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: niku kasmai ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 3748972
• MDR Text Key: 4483198
• Report Number: 0002249697-2014-01172
• Device Sequence Number: 1
• Product Code: MEH
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K093644
• 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: 03/18/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/14/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2018
• Device Catalogue Number: 1236-2-848
• Device Lot Number: 46238401
• Other Device ID Number: STER. LOT 1312C271
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/09/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/09/2013
• 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): Hospitalization; Required Intervention
• Patient Age: 70 YR
• Patient Weight: 61