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

Catalog Number 1236-2-848

Device Problem Material Separation (1562)

Patient Problem No Code Available (3191)

Event Date 11/24/2014

Event Type  Injury  

Event Description

Patient dislocated with mdm.A closed reduction could not be performed.X-rays suggested a disassociation of the depuy head and stryker mdm insert.Revision surgery was performed and a disassociation was observed.A constrained liner was implanted 690-00-22e and a smith and nephew 22mm head was used as depuy does not offer 22mm heads.

Manufacturer Narrative

Additional information has been requested and if received, will be provided in the supplemental report upon completion of the investigation.Device not available.

Manufacturer Narrative

An event regarding off label use involving an adm liner was reported.Conclusion: the surgical protocol outlines that the adm insert under the scope of this investigation is only compatible only with 22.2 or 28mm stryker heads.Based on the provided information it has been determined that this event is associated with an off-label application.

Event Description

Patient dislocated with mdm.A closed reduction could not be performed.X-rays suggested a disassociation of the depuy head and stryker mdm insert.Revision surgery was performed and a disassociation was observed.A constrained liner was implanted 690-00-22e and a smith and nephew 22mm head was used as depuy does not offer 22mm heads.

• 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: beverly lima ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 4352361
• MDR Text Key: 5178041
• Report Number: 0002249697-2014-04801
• Device Sequence Number: 1
• Product Code: MEH
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 11/24/2014

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 Expiration Date: 09/30/2019
• Device Catalogue Number: 1236-2-848
• Device Lot Number: 49203701
• Other Device ID Number: STER. LOT 1608U501
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/12/2015
• Initial Date FDA Received: 12/22/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/10/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/02/2014
• 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: 65 YR