MAUDE Adverse Event Report: ASCENSION ORTHOPEDICS MODULAR RADIAL HEAD STEM SZ. 01 WW

Catalog Number MRH-350-01

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Loss of Range of Motion (2032)

Event Date 04/18/2018

Event Type  Injury  

Manufacturer Narrative

The device will not be returned to the manufacturer for analysis.The plant investigation is in progress and a supplemental medwatch report will be submitted upon completion of the investigation.Linked to mfr.Report number: 1651501-2018-00027.

Event Description

This is 1 of 2 reports.It was reported that on (b)(6) 2018, a patient fell and complained of pain and impaired range of motion while an mrh-350-20s-ww modular radial head sz.20s ww was attached.Subsequently, a revision surgery was performed.No additional information was provided after several attempts.

Manufacturer Narrative

The device was returned to the manufacturer for evaluation.An investigation of the device records was conducted by the manufacturer.A visual examination of the components was performed assisted by a stereomicroscope and oblique lighting.Visual examination revealed an intact implant, with the stem to head taper firmly engaged.The head articulating surface retained a bright ¿mirror-like¿ polish, with no apparent scarring from use.The records review found that the components satisfied all applicable manufacturing specifications.Potential root cause: apparent loosening of the mrh implant due to a traumatic injury.

• Brand Name: MODULAR RADIAL HEAD STEM SZ. 01 WW
• Type of Device: MODULAR RADIAL HEAD
• Manufacturer (Section D): ASCENSION ORTHOPEDICS; 8700 cameron road #100; 8700 cameron road #100; austin TX 78754
• Manufacturer (Section G): ASCENSION ORTHOPEDICS; 8700 cameron road #100; austin TX 78754
• Manufacturer Contact: vivian nelson ; 311 enterprise drive; plainsboro, NJ 08536 ; 6099362393
• MDR Report Key: 7491090
• MDR Text Key: 107561577
• Report Number: 1651501-2018-00026
• Device Sequence Number: 1
• Product Code: KWI
• Combination Product (y/n): N
• PMA/PMN Number: K032686
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Dental Hygienist
• Type of Report: Initial,Followup
• Report Date: 04/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/07/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: MRH-350-01
• Device Lot Number: 10-0192
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/20/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/11/2018
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention