MAUDE Adverse Event Report: TORNIER S.A.S. RHS RADIAL HEAD DIA 24MM; PROSTHESIS, ELBOW, SEMI-CONSTRAINED, CEMENTED

Model Number	DTJ304
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Discomfort (2330)
Date of Event	12/02/2022
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.
Event or Problem Description
It was reported that the patient had a revision.The patient was initially doing well post-operatively and denies any injury or trauma.The patient presented to a routine follow up visit and was noted to have complete dissociation of the head from the stem.At the time the patient was noticing some mechanical symptoms, but denies an acute episode.We discussed revision vs.Removal and the patient and family elected to proceed with exploration and revision.Revision surgery was performed.At the time of surgery, the stem was well fixed and in good position, we placed a larger head and it snapped onto the stem appropriately.The patient was initially doing well, again with multiple follow ups showing stable prosthesis, but then returned to the office when they felt something didn¿t feel right.The patient denies an acute event or injury.Radiographs showed that the head had once again dissociated from the stem.The patient was taken back to the operating room where the entire prosthesis was removed and they was left with radial head excision.
Additional Manufacturer Narrative
The reported event could be confirmed since the x-rays were provided for investigation.The device inspection was not possible as the product was not returned for investigation.Since x-rays was provided, the opinion of the medical expert was requested and stated as following: the x-rays can confirm the reported events.The stryker/tornier long stem rhs prosthesis is implanted in a proper fashion.From the information at hand, the medical expert cannot find any irregularity that would explain the repeated disengagement of the radial head component.More detailed information about the complaint event as well as the affected device must be available in order 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.If the device is returned or if any additional information is provided, the investigation will be reassessed.
Event or Problem Description
It was reported that the patient had a revision.The patient was initially doing well post-operatively and denies any injury or trauma.The patient presented to a routine follow up visit and was noted to have complete dissociation of the head from the stem.At the time the patient was noticing some mechanical symptoms, but denies an acute episode.We discussed revision vs.Removal and the patient and family elected to proceed with exploration and revision.Revision surgery was performed.At the time of surgery, the stem was well fixed and in good position, we placed a larger head and it snapped onto the stem appropriately.The patient was initially doing well, again with multiple follow ups showing stable prosthesis, but then returned to the office when they felt something didn¿t feel right.The patient denies an acute event or injury.Radiographs showed that the head had once again dissociated from the stem.The patient was taken back to the operating room where the entire prosthesis was removed and they was left with radial head excision.

• Brand Name: RHS RADIAL HEAD DIA 24MM
• Common Device Name: PROSTHESIS, ELBOW, SEMI-CONSTRAINED, CEMENTED
• Manufacturer (Section D): TORNIER S.A.S.; 161 rue lavoisier; montbonnot saint-martin 38330 ; FR 38330
• Manufacturer (Section G): WRIGHT MEDICAL CORK (TORNIER ORTHOPEDICS IRELAND LTD); harnetts cross; macroom, co. cork 38330 ; EI 38330
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 16057443
• Report Number: 3000931034-2022-00389
• Device Sequence Number: 11985978
• Product Code: JDB
• UDI-Device Identifier: 03700386927065
• UDI-Public: 03700386927065
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K060438
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/02/2023

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?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: DTJ304
• Device Catalogue Number: DTJ304
• Device Lot Number: 7973AX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/02/2022
• Supplement Date Received by Manufacturer: 02/02/2023
• Initial Report FDA Received Date: 12/27/2022
• Supplement Report FDA Received Date: 03/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/30/2022
• 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: 60 YR
• Patient Sex: Female
• Patient Weight: 59 KG