MAUDE Adverse Event Report: ASCENSION ORTHOPEDICS CMRH STEM SZ. 03S; CARBON MRH

Catalog Number CMRH-310-S03S-WW

Device Problem Mechanical Problem (1384)

Patient Problem Injury (2348)

Event Date 04/16/2019

Event Type  Injury  

Manufacturer Narrative

Lot 18470 provided for the cmrh stem implant does not correspond to an integra lot number and is likely missing a digit.The devices (implant and trial) have not been returned to ils-austin; therefore, no failure analysis can be conducted.

Event Description

2 of 2 complaints: other mfg report number - 1651501-2019-00018.It was reported that during surgery on (b)(6) 2019, the implant stem (id trl-310-03 - cmrh stem trial sz.03) did not sit to the same depth that the trial did.It seemed that the trial size and implant size did not align.There became a fissure in the bone by the stem being driven deeper.No other patient injury was reported, and the device remains implanted in the patient.

• Brand Name: CMRH STEM SZ. 03S
• Type of Device: CARBON MRH
• 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: 8632044
• MDR Text Key: 145842931
• Report Number: 1651501-2019-00019
• Device Sequence Number: 1
• Product Code: KWI
• Combination Product (y/n): N
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: CMRH-310-S03S-WW
• Device Lot Number: 18470
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/02/2019
• 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