MAUDE Adverse Event Report: TORNIER INC AEQUALIS FLEX REVIVE PROXIMAL BODY 11DIA; PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED

Model Number	ARS741702
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	01/14/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device is currently being returned.If additional information becomes available, it will be provided in a supplemental report.
Event or Problem Description
We had to revise because the morse taper from implant dwf520 and ars741702 did not engage during first revision, so surgeon wanted to make sure the morse taper mechanics were sound.Periprosthetic fracture was treated.The event was resolved with stem upsized to a 13 and a thicker tray was used as well.
Additional Manufacturer Narrative
The device is currently being returned.If additional information becomes available, it will be provided in a supplemental report.
Event or Problem Description
We had to revise because the morse taper from implant dwf520 and ars741702 did not engage during first revision, so surgeon wanted to make sure the morse taper mechanics were sound.Periprosthetic fracture was treated.The event was resolved with stem upsized to a 13 and a thicker tray was used as well.
Event or Problem Description
We had to revise because the morse taper from implant dwf520 and ars741702 did not engage during first revision, so surgeon wanted to make sure the morse taper mechanics were sound.Periprosthetic fracture was treated.The event was resolved with stem upsized to a 13 and a thicker tray was used as well.
Additional Manufacturer Narrative
The reported event could be confirmed.Explanted devices as well as x-rays were returned for evaluation and confirmed the event noted in this complaint.Visual inspection: the received flex tray and the flex revive stem construct both show signs of minimal wear in the form of scratches and marks to the outer areas of the devices.However, the morse taper of the tray and the mating hole of the flex revive proximal body exhibits fretting.This confirms that tray was off axis in the proximal body at some point.A review of the labeling did not indicate any abnormalities.The medical opinion of a medical expert was requested to evaluate the risk of this event: ¿without date and time stamps on the x-rays, the chronology of the events is difficult to assess.In one of the x-ray the taper seems to have separated completely form the revive stem.In another x-ray, this doesn¿t seem to be the case.Do these x-ray reflect the same point in time? for more efficient reviewing event dates are very helpful in assessing a case.¿ due to the lack of information available from the complaint reporter and the provided x-rays, the medical expert was unable to provide an adequate assessment of the case at this time.Follow up attempts with the complaint reporter has been met with no responses more information as well as the affected device must be available in order to determine the exact root cause of the alleged failure.If any additional information is provided, the investigation will be reassessed.

• Brand Name: AEQUALIS FLEX REVIVE PROXIMAL BODY 11DIA
• 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: 13552286
• Report Number: 3004983210-2022-00015
• Device Sequence Number: 5187126
• Product Code: HSD
• UDI-Device Identifier: 00846832069293
• UDI-Public: 00846832069293
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K181420
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/09/2022

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: Health Professional
• Device Expiration Date: 07/06/2026
• Device Model Number: ARS741702
• Device Catalogue Number: ARS741702
• Device Lot Number: AZ0521027013
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/09/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/21/2022
• Supplement Date Received by Manufacturer: 08/16/2022
• Initial Report FDA Received Date: 02/17/2022
• Supplement Report FDA Received Date: 09/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/06/2021
• 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 Sex: Unknown