MAUDE Adverse Event Report: TORNIER INC AEQUALIS FLEX REVIVE ASSEMBLY SCREW 0MM; PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED

Model Number	ARS655101
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Codes	Failure of Implant (1924); Loss of Range of Motion (2032)
Date of Event	03/22/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient reported a pop in the arm which was followed by the inability to actively raise his arm.X-ray pictures showed that the assembly screw snapped at the union of the distal stem and proximal body.After several unsuccessful attempts in surgery to pull the distal stem out of the humerus, the physician did an osteotomy to get the stem removed.The physician then used the hrp stem to replace our revive stem.
Additional Manufacturer Narrative
Device will not be returned.If additional information becomes available, it will be provided on a supplemental report.Unable to retrieve device from the hospital.
Additional Manufacturer Narrative
The reported event could not be confirmed.The device was not returned.X-rays were provided for the device; however, the event description could not be confirmed.Since data was provided, the opinion of a medical expert was sought and stated as follows: ¿the flex revive system was implanted for a revision.The x-rays show a significant amount of bone loss of the right proximal humerus.The stem is fixed distally up to the level between the distal stem and the proximal body, transferring most of the mechanical stresses to that junctional area.This may well explain why the assembly screw gave way.It is not possible to assess if the lack of sufficient bone support of the proximal body was present at the time of implantation of the device.I would need an early postoperative x-ray of the implanted flex revive for that.This is important to assess, since the ifu and optech clearly state that flex revive is indicated for revision of the devices if sufficient bone stock remains.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.If any further information is provided, the complaint report will be updated.
Event or Problem Description
It was reported that the patient reported a pop in the arm which was followed by the inability to actively raise his arm.X-ray pictures showed that the assembly screw snapped at the union of the distal stem and proximal body.After several unsuccessful attempts in surgery to pull the distal stem out of the humerus, the physician did an osteotomy to get the stem removed.The physician then used the hrp stem to replace our revive stem.

• Brand Name: AEQUALIS FLEX REVIVE ASSEMBLY SCREW 0MM
• Common Device Name: PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED
• Manufacturer (Section D): TORNIER INC; 10801 nesbitt avenue s; bloomington MN 55437
• Manufacturer (Section G): TORNIER INC; 10801 nesbitt avenue s; bloomington MN 55437
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 14146782
• Report Number: 3004983210-2022-00054
• Device Sequence Number: 15045893
• Product Code: HSD
• UDI-Device Identifier: 00846832069408
• UDI-Public: 00846832069408
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K181420
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/21/2022

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?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 06/11/2024
• Device Model Number: ARS655101
• Device Catalogue Number: ARS655101
• Device Lot Number: AZ0619079
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/22/2022
• Supplement Date Received by Manufacturer: 05/25/2022
• Initial Report FDA Received Date: 04/19/2022
• Supplement Report FDA Received Date: 06/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/11/2019
• 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: 81 YR
• Patient Sex: Male
• Patient Weight: 81 KG
• Patient Ethnicity: Hispanic