MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH V40 COCR LFIT HEAD 36MM/0; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number 6260-9-136

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

Patient Problems Pain (1994); Injury (2348)

Event Date 02/10/2017

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that the patient had components implanted (b)(6) 2014 and recently presented with 'pain'.It was reported that the patient had a revision surgery.It was reported that the explanted head and neck components present with black debris.

Manufacturer Narrative

An event regarding corrosion involving an metal head was reported.The event was confirmed.Method and results: -device evaluation and results: material analysis of the returned device was performed which concluded that "damage consistent with the explantation process was observed on the head.Discoloration was observed on the taper of the head.Eds showed the discoloration was consistent with a corrosion process, material transfer from a hip stem 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 as per provided mar of the returned device which concluded that discoloration was observed on the taper of the head.Eds showed the discoloration was consistent with a corrosion process, material transfer from a hip stem and biological material.Damage consistent with the explantation process was observed on the head.No material or manufacturing defects were observed on the surfaces examined.The root cause could not be determined because insufficient information was provided.If the additional information is received, this investigation will be reopened and re-evaluated.

Event Description

It was reported that the patient had components implanted (b)(6) 2014 and recently presented with 'pain'.It was reported that the patient had a revision surgery.It was reported that the explanted head and neck components present with black debris.

• Brand Name: V40 COCR LFIT HEAD 36MM/0
• 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: rita intorrella ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6401387
• MDR Text Key: 69841886
• Report Number: 0002249697-2017-00865
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K022077
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/04/2017

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: 08/31/2018
• Device Catalogue Number: 6260-9-136
• Device Lot Number: MMLDME
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/08/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/14/2017
• Initial Date FDA Received: 03/13/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/04/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/21/2013
• 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