MAUDE Adverse Event Report: CORIN LTD TAPERFIT; CORIN TAPERFIT HIP STEM

Model Number UNKNOWN

Device Problem Fracture (1260)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/08/2024

Event Type  Injury  

Event Description

Taperfit revision due to fracture of the stem.Date of primary surgery unknown and thus it is unknown how long the device had been implanted.

Manufacturer Narrative

(b)(4) initial report.Additional information, including date of primary surgery, confirmation on the date of revision, primary surgeon, part no.And lot code of the taperfit stem, primary usage information, what other devices were revised with the stem, post primary and pre revision x-rays, operative notes (primary and revision), patient age, activity level, medical history and weight, what the patient wasdoing at the time of the stem fracture, whether the patient followed correct post-op protocol, whether the patient experienced any slips / falls or other trauma post primary surgery, an update on the patient post revision and whether the explanted stem is available for examination, has been requested in order to progress with the investigation of this event, and if received, will be provided in a supplemental report upon completion of the investigation.Upon receipt of the appropriate device details, the relevant device manufacturing records will be identified and reviewed.Please note: this report is filed with the fda due to an adverse event experienced with a device that is similar to those placed on the market in the usa, however, this event occurred outside of the usa.The submission of this report does not constitute an admission that the device, reporting entity, entity's representative or distributor caused or contributed to this event.

• Brand Name: TAPERFIT
• Type of Device: CORIN TAPERFIT HIP STEM
• Manufacturer (Section D): CORIN LTD; the corinium centre; cirencester, gloucestershire GL7 1 YJ; UK GL7 1YJ
• Manufacturer (Section G): CORIN LTD; the corinium centre; cirencester, gloucestershire GL7 1 YJ; UK GL7 1YJ
• Manufacturer Contact: dardan uka ; the corinium centre; cirencester, gloucestershire GL7 1-YJ ; UK GL7 1YJ
• MDR Report Key: 19162045
• MDR Text Key: 340790623
• Report Number: 9614209-2024-00318
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K142761
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/23/2024

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 Model Number: UNKNOWN
• Device Catalogue Number: NOT APPLICABLE
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/18/2024
• Initial Date FDA Received: 04/23/2024
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization