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 Contamination (1120); Corroded (1131)

Patient Problems Failure of Implant (1924); Inflammation (1932); Pain (1994); Injury (2348)

Event Date 02/03/2016

Event Type  Injury  

Manufacturer Narrative

It was noted that the device is not available for evaluation.Additional information has been requested.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.

Event Description

The customer reported that the patient was originally implanted with an lfit / accolade right hip on (b)(6) 2012 and this was revised on (b)(6) 2016.The customer further reported a large bursa with fluid, posterior to hip and also black material on stem trunnion.The histology report was consistent with alval.

Manufacturer Narrative

Corrected data: device returned.An event regarding altr involving a metal head was reported.The event was not confirmed.However, the material analysis report was able to confirm corrosion.Method & results: -device evaluation and results: a material analysis was performed on the returned device which concluded: "adhered material was observed on the stem trunnion and head taper.Eds showed the stem was consistent with (b)(4) alloy, the head consistent with (b)(4) alloy and the adhered material was consistent with biological material, a corrosion process, and the stem base alloy.No material or manufacturing defects were observed on the surfaces examined." -medical records received and evaluation: a review of the provided x-rays by a clinical consultant indicated insufficient information was provided.¿no confirmation of the event, need x-rays, mri, histopathology reports, clinical past medical history, operative reports and follow-up notes.¿ -device history review: a device history review confirmed all devices accepted into finished goods conformed to specification.-complaint history review: no other events were reported for the lot indicated.Conclusions: the reported event of altr could not be determined because insufficient information was provided.However, the material analysis report was able to confirm corrosion.Further information such as x-rays, mri, histopathology reports, clinical past medical history, operative reports and follow-up notes are needed to complete the investigation for determining root cause.No further investigation for this event is possible at this time.If devices and/or additional information become available, this investigation will be reopened.

Event Description

The customer reported that the patient was originally implanted with an lfit / accolade right hip on (b)(6) 2012 and this was revised on (b)(6) 2016.The customer further reported a large bursa with fluid, posterior to hip and also black material on stem trunnion.The histology report was consistent with alval.

• 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: cindy chuhinko ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6570433
• MDR Text Key: 75272021
• Report Number: 0002249697-2017-01559
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• PMA/PMN Number: K022077
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/29/2017

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: 07/31/2016
• Device Catalogue Number: 6260-9-136
• Device Lot Number: MKKMAV
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/14/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/18/2017
• Initial Date FDA Received: 05/16/2017
• Supplement Dates Manufacturer Received: 08/04/2017
• Supplement Dates FDA Received: 08/29/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/18/2011
• 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): Hospitalization; Required Intervention
• Patient Age: 73 YR
• Patient Weight: 66