MAUDE Adverse Event Report: CORIN MEDICAL UNITY TOTAL KNEE SYSTEM; TIBIAL INSERT CS FIXED #7 TH11

Model Number 1125224

Device Problems Mechanical Problem (1384); Device Dislodged or Dislocated (2923)

Patient Problem Joint Laxity (4526)

Event Date 07/15/2022

Event Type  Injury  

Manufacturer Narrative

Per (b)(4) initial report: additional information, including the primary surgery usage ticket, the lot code of the explanted device, x-rays, operative notes, patient age, activity level, medical history and weight, if the patient experiences any slips/trauma post primary surgery, if the patient followed the correct posrt op protocol and an update on the patient post revision and why the thickness between the device implanted in the first surgery and the one implanted during the revision surgery is so important, 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.

Event Description

Unity revision after approx.8 months due to the cs insert disengaged from the tray.

Event Description

Unity revision after approx.8 months due to the cs insert disengaged from the tray.

Manufacturer Narrative

Per -4889 final report.Additional information, including the primary surgery usage ticket, the lot code of the explanted device, x-rays, operative notes, patient age, activity level, medical history and weight, if the patient experiences any slips/trauma post priamry surgery, if the patient followed the correct posrt op protocol and an update on the patient post revision and why the thickness between the device implanted in the first surgery and the one implanted during the revision surgery is so important, has been requested in order to progress with the investigation of this event.Part of this information was provided: the patient is 52 year-old male active worker, there was no injury to repprt after his primary surgery, he followed post op protocol and is doing well following the revision.The thickness difference between in the inserts implanted in the first surgery and the revision one is probably because the patient's knee stretched out somewhat and the surgeon did some soft tissue releasing during the poly swap.The 16mm insert was the snuggest and most secure fit for him.Pre-revision x-rays were also provided.Review of the x-ray and pictured confirmed the cs insert disengaged posteriorly.The femoral component was then bearing on the edge on the poly and distorted it due to weight bearing.The device details of the devices implanted during the primary surgery were provided and the relevant device manufacturing records were located and reviewed.The finished devices conformed to material and dimensional specification at the time of manufacture.Based on the above, the root cause of the issue that led to this revision is considered unknown.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.

• Brand Name: UNITY TOTAL KNEE SYSTEM
• Type of Device: TIBIAL INSERT CS FIXED #7 TH11
• Manufacturer (Section D): CORIN MEDICAL; the corinium center; cirencester, GL7 1 YJ; UK GL7 1YJ
• Manufacturer (Section G): CORIN MEDICAL; the corinium center; cirencester, GL7 1 YJ; UK GL7 1YJ
• Manufacturer Contact: dardan uka ; the corinium center; cirencester, GL7 1-YJ ; UK GL7 1YJ
• MDR Report Key: 15073695
• MDR Text Key: 296293592
• Report Number: 9614209-2022-00058
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K183533
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/25/2022

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 Model Number: 1125224
• Device Catalogue Number: NOT APPLICABLE
• Device Lot Number: 479306
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/15/2022
• Initial Date FDA Received: 07/21/2022
• Supplement Dates Manufacturer Received: 07/15/2022
• Supplement Dates FDA Received: 09/25/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/24/2021
• 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: UNITY FEMORAL COMPONENT: PART 112.001.16 LOT 45096; UNITY PATELLA: PART 112.018.10 LOT 490465; UNITY TIBIAL TRAY: PART 112.040.14 LOT 456360
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 62 YR
• Patient Sex: Male