MAUDE Adverse Event Report: TORNIER S.A.S. 8.0MM X 30MM RADIAL STEM; PROSTHESIS, ELBOW, CONSTRAINED, CEMENTED

Model Number	0830819
Medical Device Problem Codes	Osseointegration Problem (3003); Migration (4003)
Health Effect - Clinical Codes	Inadequate Osseointegration (2646); Implant Pain (4561)
Date of Event	10/01/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device will not be returned.If additional information becomes available, it will be provided on a supplemental report.Device not available.
Event or Problem Description
It was reported that the patient had post-operative complication of component loosening."since (b)(6) 2022, probably after musculation efforts, intense pain in the left elbow.X-rays show a loosening of the humeral implant (stem) and lateral deviation of the radial implant.The patient experienced pain on his prosthesis when practicing weightlifting, and during a move.He did not really follow the precautionary instructions and avoidance of carrying loads.The patient underwent a revision to remove the radial implant and change the humeral implant.The ao classification does not apply to bone loss of the humerus, ulna and radius (after 7 interventions following an open fracture in 2013 by motorcycle accident).This is well beyond c3.
Event or Problem Description
It was reported that the patient had post-operative complication of component loosening."since october 22, probably after musculation efforts, intense pain in the left elbow.X-rays show a loosening of the humeral implant (stem) and lateral deviation of the radial implant.The patient experienced pain on his prosthesis when practicing weightlifting, and during a move.He did not really follow the precautionary instructions and avoidance of carrying loads.The patient underwent a revision to remove the radial implant and change the humeral implant.The ao classification does not apply to bone loss of the humerus, ulna and radius (after 7 interventions following an open fracture in 2013 by motorcycle accident).This is well beyond c3.
Additional Manufacturer Narrative
Correction: h6 clinical code.The reported event could be confirmed.The device was not returned for evaluation; however, through the evaluation of the provided x-rays and a medical expert's opinion, the event could be confirmed.More detailed information about the complaint event as well as the affected device must be available to determine the root cause of the complaint event.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing, or design related problems were found during the investigation.The medical opinion of a medical expert was requested to evaluate the risk of this event: i carefully reviewed the documents and the x-rays that were sent to me.The patient had a complex fracture of the elbow in 2014 and underwent 7 surgeries before implantation of the total elbow arthroplasty (tea, including rh implant) in 2022.In the pre-operative situation, the patient practically had a ¿floating elbow¿ because of the bone loss including the distal humeral epicondyles and soft tissue damage.The risk of a pre-existing surgical site infection was communicated with the patient.In fact, intra-operative cultures taken during tea implantation showed staphylococcus aureus, for which the patient was treated with antibiotics for 2 months postoperatively.The x-rays confirm the alleged adverse event of tea implant loosening and radial head dislocation.The adverse event most likely is attributable to multiple factors including insufficient bone quality, lack of good soft tissue and muscular support for elbow stability, probability of persistent infection (as per distal humerus periosteal reaction on the x-ray) and overloading of the elbow because of weight-lifting activities by the patient.The confirmation/exclusion of persistent infection can be made during the revision surgery for sure.If the device is returned or if any additional information is provided, the investigation will be reassessed.

• Brand Name: 8.0MM X 30MM RADIAL STEM
• Common Device Name: PROSTHESIS, ELBOW, CONSTRAINED, CEMENTED
• Manufacturer (Section D): TORNIER S.A.S.; 161 rue lavoisier; montbonnot saint-martin MN 38330 ; FR 38330
• Manufacturer (Section G): TORNIER S.A.S.; 161 rue lavoisier; montbonnot saint-martin MN 38330 ; FR 38330
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 16567958
• Report Number: 0001649390-2023-00036
• Device Sequence Number: 12146378
• Product Code: JDC
• UDI-Device Identifier: 00846832072460
• UDI-Public: 00846832072460
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K182461
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/23/2023

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
• Operator of Device: Lay User/Patient
• Device Expiration Date: 04/19/2024
• Device Model Number: 0830819
• Device Catalogue Number: 0830819
• Device Lot Number: CZ1919003
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/20/2023
• Supplement Date Received by Manufacturer: 05/23/2023
• Initial Report FDA Received Date: 03/17/2023
• Supplement Report FDA Received Date: 05/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/19/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 63 YR
• Patient Sex: Male
• Patient Weight: 100 KG