MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH V40 COCR LFIT HEAD 36MM/+5; IMPLANT

Catalog Number 6260-9-236

Device Problems Material Separation (1562); Device Dislodged or Dislocated (2923); Device Contamination with Chemical or Other Material (2944); Naturally Worn (2988)

Patient Problem No Code Available (3191)

Event Date 03/30/2015

Event Type  Injury  

Event Description

The patient presented in the er on (b)(6) 2015 due to the head separating from the stem.The surgeon found that the trunnion had been worn considerably.There was black debris found throughout the entire hip area.Upon removing the poly from the cup, the cup had also dislodged from the bone.All implants had to be removed.New devices were then implanted successfully.

Manufacturer Narrative

Additional information has been requested and if received, will be provided in the supplemental report upon completion of the investigation.Device not available.

Manufacturer Narrative

An event regarding disassociation involving a metal femoral head was reported.The event was confirmed based on the images received of the accolade stem damage.Method and results: device evaluation and results: not performed as the reported device was not returned for evaluation.Medical records received and evaluation: a medical review performed indicated: "as such and unfortunately, root cause of failure cannot be established with the current information.Would need x-rays for component position, lab info on metal ion levels and more medical info." device history review: review indicated all devices were manufactured and accepted into final stock with no reported discrepancies.Complaint history review: review indicated there have been no other events for the reported lot.Conclusions: the exact cause of the event could not be determined because insufficient information was provided.Additional information, including operative reports, progress notes, x-rays and return of the device are needed to fully investigate the event.

Event Description

The patient presented in the er on (b)(6) 2015 due to the head separating from the stem.The surgeon found that the trunnion had been worn considerably.There was black debris found throughout the entire hip area.Upon removing the poly from the cup, the cup had also dislodged from the bone.All implants had to be removed.New devices were then implanted successfully.

• Brand Name: V40 COCR LFIT HEAD 36MM/+5
• Type of Device: IMPLANT
• 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: beverly lima ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 4724036
• MDR Text Key: 21471226
• Report Number: 0002249697-2015-01355
• 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: Other,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/30/2015

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: 10/31/2011
• Device Catalogue Number: 6260-9-236
• Device Lot Number: 19865905X1
• Other Device ID Number: STER. LOT MSH0609T
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/24/2015
• Initial Date FDA Received: 04/23/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/20/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/05/2006
• 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