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

Model Number 588.4503

Device Problems Loss of Osseointegration (2408); Loosening of Implant Not Related to Bone-Ingrowth (4002)

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

Event Date 07/18/2023

Event Type  Injury  

Event Description

Taperfit / trinity revision of the stem, biolox delta ceramic head and ecima liner after approximately 2 years and 3 months due to loosening of the stem.

Manufacturer Narrative

(b)(4) initial report.Additional information including post primary and pre revision x-rays, operative notes (primary and revision), patient medical history and activity level, whether the patient experienced any slips / falls or other trauma post primary surgery, whether the patient followed correct post-op protocol and an update on the patient post revision was requested in order to progress with the investigation of this event, however, the reporter has stated that this information cannot be provided.Therefore, the scope of the investigation is limited.The appropriate device details have been provided and 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.

Manufacturer Narrative

(b)(4) final report additional information including post primary and pre revision x-rays, operative notes (primary and revision), patient medical history and activity level, whether the patient experienced any slips / falls or other trauma post primary surgery , whether the patient followed correct post-op protocol and an update on the patient post revision was requested in order to progress with the investigation of this event, however, the reporter stated that this information could not be provided.Therefore, the scope of the investigation was limited.The appropriate device details were provided and the relevant device manufacturing records have been identified and reviewed.It was found that all finished 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 stem loosening 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.

• Brand Name: TAPERFIT
• Type of Device: 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: 17433835
• MDR Text Key: 320205430
• Report Number: 9614209-2023-00214
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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,Followup
• Report Date: 02/05/2024

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: 588.4503
• Device Lot Number: 440308
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 07/18/2023
• Initial Date Manufacturer Received: 07/18/2023
• Initial Date FDA Received: 08/01/2023
• Supplement Dates Manufacturer Received: 07/18/2023
• Supplement Dates FDA Received: 02/05/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/28/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: BIOLOX DELTA CERAMIC HEAD: 104.3605, 474695.; TAPERFIT CEMENT RESTRICTOR: 588.0002, 464143.; TRINITY CUP: 321.04.356, 463607.; TRINITY ECIMA LINER: 322.04.936, 467755.
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 68 YR
• Patient Sex: Male
• Patient Weight: 72 KG