MAUDE Adverse Event Report: CORIN MEDICAL TAPERFIT; HIP STEM

Model Number 588.3800

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Loss of Range of Motion (2032)

Event Date 02/15/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).Combined report it was reported that the patient suffers from perthes disease and the operative leg was significantly shorter than the other.The surgeon attempted to lengthen the leg during primary surgery, paying particular attention to the sciatic nerve.However, the nerve became streched / stressed and thus when the patient woke after primary surgery they were in extreme pain and had lost movement of the foot.The patient was taken straight back to theatre, the stem and head were revised and a 1cm osteotomy was performed to relieve stress on the sciatic nerve.The patient recovered well after the revision and regained movement of the foot.The appropriate device details were provided and the relevant device manufacturing records have been identified and reviewed.All finished parts associated with these records conformed to material and dimensional specification at the time of manufacture.X-rays, operative notes, patient medical history and patient activity level could not be provided.However, as the event was the result of nerve stress from primary surgery and not due to the design or performance of the corin devices, this case is now considered closed.

Event Description

Patient experienced extreme pain and loss of movement in their foot when they awaoke from primary surgery and thus were taken straight back to theatre for revision of the taperfit stem and trinity biolox delta ceramic head.Please note: the ceramic liner associated with this event report is not cleared for sale or distribution within the usa and this event occurred outside of the usa.

• Brand Name: TAPERFIT
• Type of Device: HIP STEM
• Manufacturer (Section D): CORIN MEDICAL; the corinium centre; cirencester, gloucestershire GL7 1 YJ; UK GL7 1YJ
• Manufacturer (Section G): CORIN MEDICAL; the corinium centre; cirencester, gloucestershire GL7 1 YJ; UK GL7 1YJ
• Manufacturer Contact: sean moule ; the corinium centre; cirencester, gloucestershire GL7 1-YJ ; UK GL7 1YJ
• MDR Report Key: 11403406
• MDR Text Key: 234393512
• Report Number: 9614209-2021-00023
• Device Sequence Number: 1
• Product Code: JDG
• 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: Other
• Type of Report: Initial
• Report Date: 03/03/2021

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 Model Number: 588.3800
• Device Catalogue Number: NOT APPLICABLE
• Device Lot Number: 459452
• Initial Date Manufacturer Received: 02/15/2021
• Initial Date FDA Received: 03/03/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/06/2020
• 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 - 104.3200, 443735; BIOLOX DELTA CERAMIC LINER - 321.02.432, 436107; TRINITY CUP - 321.02.346, 459383
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 32 YR