MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH C-TAPER COCR LFIT HEAD 28MM/0; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED

Catalog Number 06-2800

Device Problems Detachment Of Device Component (1104); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Injury (2348)

Event Date 02/23/2016

Event Type  Injury  

Manufacturer Narrative

Additional information has been requested and if received, will be provided in the supplemental report upon completion of the investigation.

Event Description

It was reported that there was a left hip revision on patient/ patient presented with pain came to doctor who took an x-ray which appeared to show some sort of disassociation - surgeon took another x-ray with a different machine and the second x-ray showed no issue/disassociation.Surgeon stated that patient had gained 100 lbs since primary hip surgery.Surgeon revised mdm liner, cup and head revised with regular poly and head.

Manufacturer Narrative

An event regarding dislocation involving a metal femoral head was reported.A dislocation event could not be confirmed.Method and results: device evaluation and results: visual inspection was performed as part of the material analysis report damage was observed around the articulating surfaces of the femoral head, consistent with explanation damage a material analysis concluded that " no material or manufacturing defects were observed on the device features evaluated." medical records received and evaluation: a medical review was performed and concluded "an intra-prosthetic dislocation occurred in a morbidly obese patient requiring revision surgery with liner exchange.The exact balance between patient-related and procedure related factors cannot be determined due to lack of proper information." 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 similar events for the reported lot.Conclusions: a material was performed and concluded that "no material or manufacturing defects were observed on the device features evaluated".The exact cause of the event however could not be determined because insufficient information was provided.Additional information, including operative reports, patient history, progress notes, x-rays and return of the device are needed to fully investigate the event.If further information becomes available, this investigation will be re-opened.

Event Description

It was reported that there was a left hip revision on patient/ patient presented with pain came to doctor who took an x-ray which appeared to show some sort of disassociation - surgeon took another x-ray with a different machine and the second x-ray showed no issue/disassociation.Surgeon stated that patient had gained 100 lbs since primary hip surgery.Surgeon revised mdm liner, cup and head revised with regular poly and head.

• Brand Name: C-TAPER COCR LFIT HEAD 28MM/0
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED
• 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: keyla colon ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 5505295
• MDR Text Key: 40527946
• Report Number: 0002249697-2016-00860
• Device Sequence Number: 1
• Product Code: LWJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K993601
• 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: 02/23/2016

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: 01/31/2018
• Device Catalogue Number: 06-2800
• Device Lot Number: MLTNY2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/28/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/23/2016
• Initial Date FDA Received: 03/16/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/14/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/24/2013
• 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: 63 YR