MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH MOD CON DIST STEM 19 X 195 MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number 6276-7-119

Device Problems No Apparent Adverse Event (3189); Insufficient Information (3190)

Patient Problems Injury (2348); Non-union Bone Fracture (2369)

Event Date 08/12/2015

Event Type  Injury  

Manufacturer Narrative

Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.

Event Description

Patient underwent revision for mechanical problems with the head-neck taper junction.Patient underwent femoral osteotomy for non-union.Modular head and neck revised.

Manufacturer Narrative

An event regarding corrosion involving a ceramic head and restoration modular body was reported.Conclusion: based on the provided information, the product reported in this investigation did not contribute to the event.The event reported corrosion involving femoral devices: ceramic head and restoration modular body.There is no allegation of failure against the restoration modular stem.No further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.

Event Description

Patient underwent revision for mechanical problems with the head-neck taper junction.Patient underwent femoral osteotomy for non-union.Modular head and neck revised.

• Brand Name: MOD CON DIST STEM 19 X 195 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: beverly lima ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 5323610
• MDR Text Key: 34256819
• Report Number: 0002249697-2015-04484
• 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
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/08/2015

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: 06/30/2019
• Device Catalogue Number: 6276-7-119
• Device Lot Number: CAXP753A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/08/2015
• Initial Date FDA Received: 12/23/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/24/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/14/2014
• 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: 71 YR
• Patient Weight: 88