MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH V40 COCR LFIT HEAD 36MM/+5; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number 6260-9-236

Device Problems Corroded (1131); Metal Shedding Debris (1804); Material Integrity Problem (2978)

Patient Problems Pain (1994); Injury (2348); Reaction (2414)

Event Date 02/22/2017

Event Type  Injury  

Manufacturer Narrative

It was noted that the device is not available for evaluation.Additional information has been requested and if received, will be provided in the supplemental report upon completion of the investigation.

Event Description

Sales rep reported a revision surgery of hip due to pain and metallic debris per surgeon.

Manufacturer Narrative

An event regarding corrosion involving an metal head was reported.The event was confirmed.Method & results: -device evaluation and results: material analysis has been performed and indicated "discoloration was observed on the taper of the head.Eds showed the discoloration on the head was consistent with a corrosion process, material transfer, and biological material.No material or manufacturing defects were observed on the surfaces examined." -medical records received and evaluation: no medical records or x-rays were made available for evaluation.-device history review: device history review indicated the devices accepted into final stock from the reported lot were free from discrepancies -complaint history review: there has been no other event for the lot referenced.Conclusions: the event was confirmed on the basis of mar the investigation conclude that discoloration was observed on the taper of the head.Eds showed the discoloration on the head was consistent with a corrosion process, material transfer, and biological material.No material or manufacturing defects were observed on the surfaces examined.The root cause could not be determined because insufficient information was provided and further information such as histopathology reports are needed to complete the investigation for determining the root cause.If the additional information is received, this investigation will be reopened and re-evaluated.

Event Description

Sales rep reported a revision surgery of hip due to pain and metallic debris per surgeon.

• Brand Name: V40 COCR LFIT HEAD 36MM/+5
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• 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: cindy chuhinko ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6423111
• MDR Text Key: 70520336
• Report Number: 0002249697-2017-00986
• 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: health professional,other
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/24/2017

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: 10/31/2019
• Device Catalogue Number: 6260-9-236
• Device Lot Number: MNNT28
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/29/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/22/2017
• Initial Date FDA Received: 03/21/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/24/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/02/2014
• 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