MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH MOD CON DIST STEM 15 X 155 MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number 6276-7-015

Device Problems Crack (1135); Fracture (1260); Loss of Osseointegration (2408)

Patient Problem Injury (2348)

Event Date 05/18/2018

Event Type  Injury  

Manufacturer Narrative

Material analysis, visual, functional and dimensional inspections could not be performed as the device was not returned.Review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other events for the reported lot.Conclusion: review of these records confirms failure of the femoral component of a restoration modular femoral stem necessitating revision surgery.The root cause cannot be determined as insufficient information was available.It should be noted however, that he patients right hip had multiple previous operations including revision tha.During the revision of 2014 a trochanteric plate with cables was placed on the proximal femur.The reason for the fixation device is likely to be fracture or controlled proximal femoral osteotomy either of which could compromise proximal fixation of the femoral component.Assuming the stem was still well fixed distally the stress concentrate at the junction of fixed/nonfixed and repetitive load could lead to stem failure.

Event Description

Failed revision total hip.Patient was being watched for loose stem by surgeon and was planning on revision upon retirement.Due to stem failure revision was necessary at this time by a different surgeon.

• Brand Name: MOD CON DIST STEM 15 X 155 MM
• 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: joann lavatelli ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 7602934
• MDR Text Key: 111110618
• Report Number: 0002249697-2018-01815
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 04546540643735
• UDI-Public: 04546540643735
• 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
• Report Date: 06/14/2018

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2019
• Device Catalogue Number: 6276-7-015
• Device Lot Number: CAXR30XC
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/18/2018
• Initial Date FDA Received: 06/14/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2014
• 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