MAUDE Adverse Event Report: ASCENSION ORTHOPEDICS MCP SZ. 30 PROXIMAL WW

Catalog Number MCP-100-30P-WW

Device Problems Device Operates Differently Than Expected (2913); Naturally Worn (2988); Noise, Audible (3273)

Patient Problems Injury (2348); No Known Impact Or Consequence To Patient (2692)

Event Type  Injury  

Manufacturer Narrative

The device involved in the reported incident has been received for evaluation.An investigation has been initiated based on the reported information.

Event Description

It was reported that the product was implanted for 7 years and signs of excessive wear was noted during a revision surgery scheduled due to squeaking and poor functionality.No incidents during the revision surgery, the implant was replaced and the surgeon was satisfied with the result.

Manufacturer Narrative

The part was returned and underwent failure analysis.Both fracture and abrasive wear damage was evident on articulating surface of implant.Fracture damage suggest multiple events due to demanding hand function or trauma.Wear suggests subluxation or dislocation of prosthesis.However, it is not possible to identify cause of fracture and wear.Based on the information available to date, the root cause for the reported event cannot be determined.Possible causes include trauma.If additional information is received, the investigation will be updated.

• Brand Name: MCP SZ. 30 PROXIMAL WW
• Type of Device: MCP
• 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: 7318241
• MDR Text Key: 101660554
• Report Number: 1651501-2018-00015
• Device Sequence Number: 1
• Product Code: NEG
• Combination Product (y/n): N
• PMA/PMN Number: P000057
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: MCP-100-30P-WW
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/02/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/19/2018
• 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