MAUDE Adverse Event Report: TORNIER INC PERFORM REV INSERT SZ 1/2, 39MM DIA, +3; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Model Number	DWP1393
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Joint Laxity (4526); Implant Pain (4561)
Date of Event	02/01/2023
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 disposition is unknown.
Event or Problem Description
It was reported that a patient had a clunking in the shoulder during external rotation during physical therapy.Activity was modified to limit sensation of instability in er and a in person follow up was scheduled.During the 6 week post op, the patient noted that they "jammed his shoulder and it hurt for a few days" but was doing much better.At the rescheduled on (b)(6) 2023 visit x-rays showed "reverse total shoulder arthroplasty that is reduced although with subluxation of the humeral component and loosening; piton anchor moved outside of bone".Labs to rule out infection including crp, sed rate and cbc were collected and showed no indication of infection.On a subsequent date, the revision surgery occurred.The humeral and liner components were extracted and replaced with a perform long stem and constrain liner (polyethylene liner was unable to be dissociated from the humeral component).Subject in stable condition postoperatively.
Event or Problem Description
It was reported that a patient had a clunking in the shoulder during external rotation during physical therapy.Activity was modified to limit sensation of instability in er and a in person follow up was scheduled.During the 6 week post op, the patient noted that they "jammed his shoulder and it hurt for a few days" but was doing much better.At the rescheduled on (b)(6) 2023 visit x-rays showed "reverse total shoulder arthroplasty that is reduced although with subluxation of the humeral component and loosening; piton anchor moved outside of bone".Labs to rule out infection including crp, sed rate and cbc were collected and showed no indication of infection.On a subsequent date, the revision surgery occurred.The humeral and liner components were extracted and replaced with a perform long stem and constrain liner (polyethylene liner was unable to be dissociated from the humeral component).Subject in stable condition postoperatively.
Additional Manufacturer Narrative
Please note the corrections made to the h6 clinical signs code and health impact code: the reported event could be confirmed since x-rays were provided for evaluation that shows subluxation of the implant prothesis in the humerus in relation to the glenoid component.The opinion of the medical expert was requested and stated as following: the case has been discussed with the surgeon, and the subsidence of the implant was attributed to the combination of poor bone quality (patient-related factor) and possibly undersizing of the component (user-related factor).A device inspection was not possible since the affected device was not returned, and only x-rays were provided for the investigation.A review of the labeling and the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.More information as well as the affected device must be available in order to determine if the root cause of the alleged failure is user-related, patient-related or a combination of the two.If any additional information is provided, the investigation will be reassessed.

• Brand Name: PERFORM REV INSERT SZ 1/2, 39MM DIA, +3
• Common Device Name: SHOULDER PROSTHESIS, REVERSE CONFIGURATION
• 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: 16552660
• Report Number: 0001649390-2023-00034
• Device Sequence Number: 14176323
• Product Code: PHX
• UDI-Device Identifier: 00846832084432
• UDI-Public: 00846832084432
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K201315
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/17/2023

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 Model Number: DWP1393
• Device Catalogue Number: DWP1393
• Device Lot Number: AE3271005
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/17/2023
• Supplement Date Received by Manufacturer: 06/19/2023
• Initial Report FDA Received Date: 03/16/2023
• Supplement Report FDA Received Date: 07/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/16/2022
• 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: 76 YR
• Patient Sex: Male
• Patient Weight: 71 KG