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

Catalog Number 6260-9-036

Device Problem Insufficient Information (3190)

Patient Problems Cyst(s) (1800); Edema (1820); Injury (2348)

Event Date 10/24/2018

Event Type  Injury  

Manufacturer Narrative

A review of the device history records indicates that the reported devices were manufactured and accepted into final stock with no reported discrepancies.The complaint history review indicated that there were no similar events for the reported lot.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.Not returned to the manufacturer.

Event Description

Total hip was painful.A revision was performed and changed the femoral head and placed a new acetabular liner.Surgeon reported he believes possible cause/ contributor of pain was trunnionosis with a pseudotumor.

Event Description

Total hip was painful.A revision was performed and changed the femoral head and placed a new acetabular liner.Surgeon reported he believes possible cause/ contributor of pain was trunnionosis with a pseudotumor.

Manufacturer Narrative

An event regarding disassociation (trunnionosis), altr and pain involving a metal head was reported.Revision surgery for pain was confirmed following clinician review.Disassociation (trunnionosis) and altr was not confirmed.Method & results: device evaluation and results: visual inspection: although the device was not returned an image of the device was made available.Some discoloration is noted in the taper of the metal head.The device is otherwise unremarkable.Medical records received and evaluation: a review of the provided medical records and x-rays by a clinical consultant indicated: [.] review of these records confirms revision tha surgery for pain occurred, however, the root cause cannot of the pain be determined as insufficient information was available[.] device history review: all devices were manufactured and accepted into final stock with no relevant reported discrepancies.Complaint history review: there have been no other similar events for the reported lot.Conclusion: no further investigation is required at this time.The exact cause of the event could not be determined because insufficient information was provided.Additional information such as surgical implant records from the surgeries.Dated pre and post op x-ray from the index and revision surgeries, post operative mris and reports from the index and revision surgeries, outpatient office/clinic notes, pathology reports and implant retrieval and material analysis are needed to fully investigate the event.If further information becomes available or the product is returned, this investigation will be re-opened.

• Brand Name: V40 COCR LFIT HEAD 36MM/-5
• Type of Device: HIP JOINT METAL/POLYMER SEMI-CONSTRAINED CEMENTED PROSTHESIS.
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 8091237
• MDR Text Key: 128025209
• Report Number: 0002249697-2018-03782
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 07613327032291
• UDI-Public: 07613327032291
• Combination Product (y/n): N
• PMA/PMN Number: K173499
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Type of Report: Initial,Followup
• Report Date: 01/15/2019

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: 10/30/2018
• Device Catalogue Number: 6260-9-036
• Device Lot Number: MMMPPT
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/24/2018
• Initial Date FDA Received: 11/20/2018
• Supplement Dates Manufacturer Received: 12/18/2018
• Supplement Dates FDA Received: 01/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 69 YR