MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH V40 COCR LFIT HEAD 36MM/0; IMPLANT

Catalog Number 6260-9-136

Device Problems Break (1069); Corroded (1131); Degraded (1153); Metal Shedding Debris (1804); Patient-Device Incompatibility (2682); Material Integrity Problem (2978)

Patient Problems Pain (1994); Toxicity (2333); Injury (2348); Joint Swelling (2356); Reaction (2414); Test Result (2695)

Event Date 11/27/2014

Event Type  Injury  

Event Description

Surgeon informed sales rep.That revision surgery was made (b)(6) female patient had a severe thigh pain.Outcome metallosis and fluids in joint.Basic alval symptoms.The head and poly (x3) liner was revised.Stem (item# 6020-3535, lot 39172402) was left to place although trunion was damaged.Revised liner was damaged during the procedure so it is not available for investigation.36 mm ceramic head with metal sleeve was used in replacement device.Also new 36mm x3 liner (item# 623-00-36d, lot mlnjv3) was used.

Manufacturer Narrative

A supplemental report will be submitted upon completion of the investigation.

Manufacturer Narrative

Review of device history records indicates the lot was manufactured and accepted into final stock.There have been no other events for the lot referenced.The event concerning the corrosion of the head was confirmed by the material analysis report, but the root cause could not be determined due to the minimal information received.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

Surgeon informed sales rep.That revision surgery was made as (b)(6) year old female patient had a severe thigh pain.Outcome metallosis and fluids in joint.Basic alval symptoms.The head and poly (x3) liner was revised.Stem (item# 6020-3535 lot 39172402) was left to place although trunion was damaged.Revised liner was damaged during the procedure so it is not available for investigation.36 mm ceramic head with metal sleeve was used in replacement device.Also new 36mm x3 liner (item# 623-00-36d lot mlnjv3) was used.

• Brand Name: V40 COCR LFIT HEAD 36MM/0
• 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: 4354064
• MDR Text Key: 16994049
• Report Number: 0002249697-2014-04853
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• Reporter Country Code: FI
• PMA/PMN Number: K022077
• 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: 11/27/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2017
• Device Catalogue Number: 6260-9-136
• Device Lot Number: MLNLPJ
• Other Device ID Number: STERILE LOT MSHLP02A3
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/22/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/03/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/02/2012
• 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: 63 YR
• Patient Weight: 75