MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH V40 COCR LFIT HEAD 36MM/+10; IMPLANT

Catalog Number 6260-9-336

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Local Reaction (2035)

Event Date 03/30/2015

Event Type  Injury  

Event Description

Patient had adverse local tissue reaction.Surgeon revised patient's left hip.Stryker replacements were used.

Manufacturer Narrative

An evaluation of the device cannot be performed as the device was not returned due to hospital policy.Should additional information become available it will be reported in a supplemental report upon completion of the investigation.

Manufacturer Narrative

An event regarding altr involving a metal head was reported.The event was not confirmed.Method & results: the device was not returned for analysis.Insufficient information was received for review with a clinical consultant.Review of the dhr indicated all devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the reported lot.Conclusions: the exact cause of the event could not be determined because insufficient information was provided.Additional information, including return of device, x-rays, pathology report, operative reports and progress notes are needed to fully investigate the event.If further information and/or device become available, this investigation will be re-opened.

Event Description

Patient had adverse local tissue reaction.Surgeon revised patient's left hip.Stryker replacements were used.

• Brand Name: V40 COCR LFIT HEAD 36MM/+10
• 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: keyla navedo ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 4714843
• MDR Text Key: 5664202
• Report Number: 0002249697-2015-01318
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K022077
• 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: 03/30/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2016
• Device Catalogue Number: 6260-9-336
• Device Lot Number: MKN1HL
• Other Device ID Number: STERILE LOT# MSHKP31A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/04/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2011
• 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: 64 YR
• Patient Weight: 84