MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH 22.2MM STD V40 HEAD; IMPLANT

Catalog Number 6260-4-122

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Host-Tissue Reaction (1297)

Event Date 12/13/2013

Event Type  Injury  

Event Description

It was reported that the components were revised due to adverse local tissue reaction.

Manufacturer Narrative

An event regarding altr involving a metal head was reported.The event was not confirmed.A visual, functional and dimensional inspection was not performed as the device was not returned due to hospital policy.A device history review indicated that all devices in the reported lot were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the reported lot.The exact cause of the event could not be determined because additional information is needed to investigate this event further.

Event Description

It was reported that the components were revised due to adverse local tissue reaction.

Manufacturer Narrative

It was noted that the device is not available for evaluation due to hospital policy.Additional information has been requested and if received, will be provided in the supplemental report.

• Brand Name: 22.2MM STD V40 HEAD
• 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: 3556443
• MDR Text Key: 4752244
• Report Number: 0002249697-2014-00040
• Device Sequence Number: 1
• Product Code: LWJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K993601
• 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: 12/13/2013

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: 07/25/2013
• Device Catalogue Number: 6260-4-122
• Device Lot Number: 44684601
• Other Device ID Number: STER. LOT 1307UCM
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/29/2014
• Initial Date FDA Received: 01/07/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/01/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/25/2013
• 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: 82 YR
• Patient Weight: 82