MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH 32MM +4 LFIT V40 HEAD; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number 6260-9-232

Device Problems Material Discolored (1170); Device Slipped (1584); Insufficient Information (3190)

Patient Problems Pain (1994); Injury (2348); Inadequate Osseointegration (2646); No Information (3190)

Event Date 02/06/2017

Event Type  Injury  

Manufacturer Narrative

It was noted that the device is not available for evaluation.Additional information has been requested and if received, will be provided in the supplemental report upon completion of the investigation.

Event Description

Patient presented with hip pain and a loose cup, black staining was apparent around the stem trunion and on the inside of the 32mm +4 head.

Manufacturer Narrative

An event regarding loose cup and black staining around the stem trunnion involving a metal head was reported.The event was not confirmed.Method and results: -device evaluation and results: a visual, functional and dimensional inspection could not be performed as the device was not returned.-medical records received and evaluation: the provided medical information was submitted to a consulting clinician who indicated that x-ray confirms loosening of the cup but deemed the information insufficient and rejected it for a medical review.-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 could not be confirmed nor could the root cause of black staining inside the femoral head and stem trunnion be determined because the insufficient medical information was provided.Further information such as return of device, primary and revision operative reports, past/clinical medical history, needed serial x-rays, and examination of explanted components and patient history are needed to investigate this event further.If additional information and/or device becomes available, this investigation will be reopened.

Event Description

Patient presented with hip pain and a loose cup, black staining was apparent around the stem trunion and on the inside of the 32mm +4 head.

• Brand Name: 32MM +4 LFIT V40 HEAD
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-CORK; ida industrial estate; carrigtwohill NA
• Manufacturer Contact: keyla colon ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6372267
• MDR Text Key: 68815306
• Report Number: 0002249697-2017-00759
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121308
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/08/2017

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: 11/30/2015
• Device Catalogue Number: 6260-9-232
• Device Lot Number: 35171703
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/06/2017
• Initial Date FDA Received: 03/02/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/08/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/04/2011
• 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: 82 YR