MAUDE Adverse Event Report: CORIN MEDICAL TAPERFIT; HIP STEM (1 HOLE)

Model Number 588.3800

Device Problems Insufficient Information (3190); Appropriate Term/Code Not Available (3191)

Patient Problems Joint Dislocation (2374); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/30/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4) initial report.Additional information, including post primary and pre revision x-rays, operative notes, patient medical history, whether the patient experienced any trauma prior to the event and an update on the patient post revision, 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.It has been reported that the explanted devices are not available to return for examination.The appropriate device details were provided and the relevant device manufacturing records have been identified and reviewed.All parts associated with these records conformed to material and dimensional specification at the time of manufacture.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.

Event Description

Taperfit revision after approximately 1 month and 2 weeks due to dislocation.

Manufacturer Narrative

Per -3767 final report additional information, including post primary and pre revision x-rays, operative notes, patient medical history, whether the patient experienced any trauma prior to the event and an update on the patient post revision, was requested in order to progress with the investigation of this event, however, this information was not provided and thus the scope of the investigation was limited.It has been reported that the explanted devices are not available to return for examination.The appropriate device details were provided and the relevant device manufacturing records have been identified and reviewed.All parts associated with these records conformed to material and dimensional specification at the time of manufacture.Based on the available information, no further investigation can be conducted and the root cause of the reported dislocation could not be determined.Therefore, this case is now considered closed, however, should any additional information be provided then this case may be re-opened for further investigation.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.

Event Description

Taperfit revision after approximately 1 month and 2 weeks due to dislocation.

• Brand Name: TAPERFIT
• Type of Device: HIP STEM (1 HOLE)
• Manufacturer (Section D): CORIN MEDICAL; the corinium centre; cirencester, gloucestershire GL7 1 YJ; UK GL7 1YJ
• MDR Report Key: 11824161
• MDR Text Key: 251693100
• Report Number: 9614209-2021-00064
• Device Sequence Number: 1
• Product Code: JDG
• Combination Product (y/n): N
• PMA/PMN Number: K142761
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 06/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/14/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 588.3800
• Device Catalogue Number: NOT APPLICABLE
• Device Lot Number: 464144
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: TAPERFIT CEMENT RESTRICTOR: 588.0001, 467192; TAPERFIT CEMENT RESTRICTOR: 588.0001, 467192
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 79 YR