MAUDE Adverse Event Report: ASCENSION ORTHOPEDICS LMP IMPLANT SIZE 30; TOE JOINT REPLACEMENT

Catalog Number LMP-30T

Device Problem Material Integrity Problem (2978)

Patient Problem Bone Fracture(s) (1870)

Event Type  Injury  

Manufacturer Narrative

An investigation has been initiated based on the reported information.Upon completion of the investigation, a follow-up report will be submitted.

Event Description

A physician reported a patient had implanted a lmp silicone joint and her 2nd metatarsal fractured.The implant was removed on (b)(6) 2021.

Manufacturer Narrative

Additional information received: implantation date was on (b)(6) 2021 and it was replaced on (b)(6) 2021.Type of silastic implant used for revision surgery is wright medical lateral toe and pin.Lmp implant caused fracture and there were no traumatic or contributing events prior to the discovery of the fracture.Fracture date was between (b)(6) 2021 and (b)(6) 2021.

Event Description

N/a.

Manufacturer Narrative

Toe joint replacement (lmp-30t lmp implant size 30) was not returned for evaluation; therefore, an evaluation of the device could not be performed.The cause(s) of the difficulty reported by the customer could not be determined.If additional relevant information becomes available in the future, this complaint will be reopened, and the respective evaluation performed.Trends will be monitored for this and similar issues.At present, we consider this complaint to be closed.

Event Description

N/a.

• Brand Name: LMP IMPLANT SIZE 30
• Type of Device: TOE JOINT REPLACEMENT
• Manufacturer (Section D): ASCENSION ORTHOPEDICS; 8700 cameron road #100; 8700 cameron road #100; austin TX
• MDR Report Key: 11942992
• MDR Text Key: 254524284
• Report Number: 1651501-2021-00014
• Device Sequence Number: 1
• Product Code: KWH
• Combination Product (y/n): N
• PMA/PMN Number: K023531
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 09/29/2021

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: 08/26/2021
• Device Catalogue Number: LMP-30T
• Device Lot Number: CT0216230
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/10/2021
• Initial Date FDA Received: 06/04/2021
• Supplement Dates Manufacturer Received: 07/08/2021; 09/15/2021
• Supplement Dates FDA Received: 07/29/2021; 09/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1