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

Model Number 6260-9-036

Device Problems Material Fragmentation (1261); Insufficient Information (3190)

Patient Problems Foreign Body Reaction (1868); Inflammation (1932); Injury (2348); Reaction (2414)

Event Date 11/19/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that the patient's left hip was revised due to metallosis (elevated ion levels) and trunnionosis.A 36 -5 cocr lfit head and 36 neutral liner were revised to a ceramic head and sleeve with a new poly liner.The accolade ii stem was not revised.Rep confirmed there are no allegations against the revised liner, and reported that no further information will be available.

Manufacturer Narrative

Reported event: an event regarding metallosis (elevated ion levels) and trunnionosis (fretting) involving a metal head was reported.The event was not confirmed.Method & results: product evaluation and results: not performed as no product was returned for evaluation.Medical records received and evaluation: no medical records were received for review with a clinical consultant.   device history review: indicated all devices manufactured were accepted into final stock free from discrepancies.Complaint history review: there have been no other similar events for the reported lot.  conclusion: the exact cause of the event could not be determined because insufficient information was provided.Further information such as return of the device, pre- and post-operative x-rays, primary operative report as well as patient history 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 to indicate further evaluation is warranted, this record will be reopened.

Event Description

It was reported that the patient's left hip was revised due to metallosis (elevated ion levels) and trunnionosis.A 36 -5 cocr lfit head and 36 neutral liner were revised to a ceramic head and sleeve with a new poly liner.The accolade ii stem was not revised.Rep confirmed there are no allegations against the revised liner, and reported that no further information will be available.

• 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
• MDR Report Key: 9483122
• MDR Text Key: 177401698
• Report Number: 0002249697-2019-04040
• 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: 05/05/2021

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: 10/31/2022
• Device Model Number: 6260-9-036
• Device Catalogue Number: 6260-9-036
• Device Lot Number: T35A6N
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/19/2019
• Initial Date FDA Received: 12/17/2019
• Supplement Dates Manufacturer Received: 04/16/2021
• Supplement Dates FDA Received: 05/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 71 YR