MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH ALUMINA CERAMIC INSERT 28/39G 28MM ID; IMPLANT

Catalog Number 4930-7-039

Device Problem Malposition of Device (2616)

Patient Problem No Code Available (3191)

Event Date 11/28/2014

Event Type  Injury  

Event Description

Doctor reported: "due to mobilization, revision surgery of the cup was performed.At the same also the femoral head was replaced for geometrical prosthetic reason".

Manufacturer Narrative

An evaluation of the device cannot be performed as the device was not returned to the manufacturer.Additional information was requested and if it becomes available, the evaluation summary will be submitted in a supplemental report.The subject device is not cleared for sale in the u.S., but a similar device is commercially available in the u.S.

Manufacturer Narrative

Reported event: an event regarding malposition and loosening involving an abg ii shell was reported.Conclusion: based on the provided information, the liner reported in this investigation was explanted because the shell had to be replaced, therefore the liner did not contribute to the event.No further investigation is required at this time.

Event Description

Doctor reported: "due to mobilization, revision surgery of the cup was performed.At the same also the femoral head was replaced for geometrical prosthetic reason".

• Brand Name: ALUMINA CERAMIC INSERT 28/39G 28MM ID
• 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: william hanna ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 4405025
• MDR Text Key: 5367695
• Report Number: 0002249697-2015-00017
• Device Sequence Number: 1
• Product Code: MRA
• Combination Product (y/n): N
• Reporter Country Code: IT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 12/12/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2005
• Device Catalogue Number: 4930-7-039
• Device Lot Number: GX419505
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/24/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/04/2000
• 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: 61 YR