MAUDE Adverse Event Report: CORIN MEDICAL TRINITY; ACETABULAR HIP SYSTEM WITH HXLPE LINERS

Model Number 321.02.632

Device Problems Break (1069); Naturally Worn (2988); Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/05/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4) initial report.Additional information, including device lot codes, post primary and pre revision x-rays, operative notes, patient details, patient medical history 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.The explanted devices are available and are being returned to corin for examination.Upon receipt of the appropriate device details, the relevant device manufacturing records will be identified and reviewed.

Event Description

Trinity revision of the modular head and hxlpe liner after approximately 6 years and 9 months due to excessive poly wear of the liner.

Manufacturer Narrative

Per -3453 final report.Additional information, including device lot codes, post primary and pre revision x-rays, operative notes, patient details, patient medical history and an update on the patient post revision was requested in order to progress with the investigation of this event, however, none of this information was provided and thus the scope of the investigation was limited.The explanted devices were returned to corin and examined.During this review the lot code of the associated head could be identified but the lot code on the liner was unreadable.The relevant device manufacturing records for the associated head have been identified and reviewed.All parts associated with this record conformed to material and dimensional specification at the time of manufacture.Based on the available information and from review of the explanted devices it has been concluded that the liner dislodged from the cup when the patient was reportedly moving their leg in a circumduction movement.This then led to the head articulating against the rim of the liner and inner surface of the shell, causing excessive wear to the poly.Therefore, this case is now considered closed, however, should any additional information be provided then this case may be re-opened for further investigation.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

Trinity revision of the modular head and hxlpe liner after approximately 6 years and 9 months due to excessive poly wear of the liner.

• Brand Name: TRINITY
• Type of Device: ACETABULAR HIP SYSTEM WITH HXLPE LINERS
• 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: marie-anne euzen ; the corinium centre; cirencester, gloucestershire GL7 1-YJ ; UK GL7 1YJ
• MDR Report Key: 11153376
• MDR Text Key: 226226993
• Report Number: 9614209-2021-00006
• Device Sequence Number: 1
• Product Code: MEH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K110087
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 321.02.632
• Device Catalogue Number: NOT APPLICABLE
• Device Lot Number: NOT PROVIDED
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/05/2021
• Was Device Evaluated by Manufacturer?: Yes
• 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: MODULAR HEAD - E321.132, LOT CODE NOT PROVIDED; TRINITY MODULAR HEAD: E321.032, 216514; MODULAR HEAD - E321.132, LOT CODE NOT PROVIDED
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Female