MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH 28X52-55MM 10 DEG HOOD INS; IMPLANT

Catalog Number 6283-6-525

Device Problems Degraded (1153); Device Operates Differently Than Expected (2913); Material Integrity Problem (2978)

Patient Problems Injury (2348); No Information (3190)

Event Date 04/08/2014

Event Type  Injury  

Event Description

It was reported that there was a right removal of an insert and head due to a failed tha.The pca stem left implanted.

Manufacturer Narrative

The 28mm standard femoral head; cat# 6284-0-128; lot# c6eyc was also listed in this report.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.When completed, the investigation results will be submitted in a supplemental report.

Manufacturer Narrative

The device wear and event of revision was confirmed.The root cause of the reported event determined due to the minimal information received.Visual inspection: the liner was returned for evaluation.The liner was worn and slightly discolored yellow, consistent with service in vivo.Damage was observed on the outer rim diameter, likely due to explantation.A review of the device history records indicates that the reported devices were manufactured and accepted into final stock with no reported discrepancies.The complaint history review indicated that there were no similar events for the reported lot.No further investigation for this event is possible at this time as insufficient information was received by stryker orthopaedics.If additional information becomes available, this investigation will be reopened.

Event Description

It was reported that there was a right removal of an insert and head due to a failed tha.The pca stem left implanted.

• Brand Name: 28X52-55MM 10 DEG HOOD INS
• Type of Device: IMPLANT
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer Contact: william hanna ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 3781290
• MDR Text Key: 4358393
• Report Number: 0002249697-2014-01607
• Device Sequence Number: 1
• Product Code: JDL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K921384
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,health professional,oth
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/08/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/30/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/06/2002
• Device Catalogue Number: 6283-6-525
• Device Lot Number: UZAPA
• Other Device ID Number: STERILE LOT# 9727986
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/17/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/24/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/06/1997
• 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: 68 YR
• Patient Weight: 85