MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH 25MM MOD REV HIP BODY/BOLT STDCOMPONENT LEVEL 9006-1-025; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number 6276-1-025

Device Problem Insufficient Information (3190)

Patient Problems Injury (2348); No Code Available (3191)

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 restoration modular body was reported.The event was not confirmed.Device history review: device history review indicated all devices were manufactured and accepted into final stock with no relevant reported discrepancies.Complaint history review: review indicated there have been no other similar events for the reported lot.Conclusions: the exact cause of the event could not be determined because insufficient information was provided.Additional information, operative reports, pathology reports, patient history, x-rays and return of the device are needed to fully investigate the event.No further investigation is required at this time.If further information becomes available or the product is returned, this investigation will be re-opened.

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: 25MM MOD REV HIP BODY/BOLT STDCOMPONENT LEVEL 9006-1-025
• 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 navedo ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 5323613
• MDR Text Key: 34256138
• Report Number: 0002249697-2015-04485
• 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: 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: 03/31/2019
• Device Catalogue Number: 6276-1-025
• Device Lot Number: 47064101
• 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: 03/04/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/31/2014
• 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