MAUDE Adverse Event Report: TORNIER S.A.S. UNKNOWN AEQUALIS REVERSED II SPHERE; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Catalog Number UNK_WTM

Device Problems Device Dislodged or Dislocated (2923); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Unspecified Infection (1930); Joint Dislocation (2374); Implant Pain (4561); Swelling/ Edema (4577)

Event Date 07/20/2023

Event Type  Injury  

Event Description

This report covers the infection that resulted in revision surgery and the dislocation discovered during the revision surgery event.As reported by the customer: "on (b)(6) 2023: fitting of a total reverse prosthesis + episcopo at hospital.Indication right eccentric omarthrosis on cuff rupture with lag sign in re.In the operative report, there is no lot number for the prosthesis.It is written: [placement of an aequalis reverse baseplate (tornier laboratory) on the asymmetric graft which positioned posterosuperior, size 29 mm, long stud, stabilized by 4 screws].4 months after fitting, infection of the prosthesis requiring repeat surgery.2nd hospitalization at hospital, as the aphm surgeon left the nord debit site on (b)(6) 2023 for this establishment." scar swelling and pain.It was decided to operate: a voluminous purulent subcutaneous collection with sampling for bacteriological examination.Opening of the deltopectoral fold: hematic appearance contact with the prosthesis.A new sample was taken.Prosthesis dislocation.Removal of polyethylene insert and humeral plate.Washing.Installation of a new plate for the ascend flex prosthesis, tornier laboratory.Start of immediate postoperative probabilistic antibiotic therapy tazocilline + zyvoxid.After 10 days, change of antibiotic therapy: 7 g amoxiciline per day with follow-up infectiologist for 1 year.Today, the 79-year-old patient suffers from pain + side effects of antibiotic treatment antibiotic treatment.".

Manufacturer Narrative

Based on the available information the device will not be returned therefore an evaluation of the device cannot be performed.A review of the device history is not possible because the lot number was not communicated.Should additional information become available, it will be provided in a supplemental report.H3 other text: device disposition unknown.

Manufacturer Narrative

Please note correction to h6 (device code and clinical signs code) the complaint couldn't be confirmed, since the device was not returned for evaluation and no other evidences were provided, to confirm the reported event.A device inspection was not possible since the affected device was not returned for investigation.The opinion of the medical expert was requested on this case despite the limited information provided, and stated as following: "there is neither a specific factor mentioned nor deducible from the description that has contributed to this event of deep infection postoperatively".A review of the device history was not possible because the lot number was not communicated.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.Indications of material, manufacturing, or design related problems were unable to be identified as the lot number was not communicated.More detailed information about the complaint event must be available in order to determine the root cause of the complaint event.If the device is returned or if any additional information is provided, the investigation will be reassessed.

Event Description

This report covers the infection that resulted in revision surgery and the dislocation discovered during the revision surgery event.As reported by the customer: "on (b)(6) 2023: fitting of a total reverse prosthesis + episcopo at hospital.Indication right eccentric omarthrosis on cuff rupture with lag sign in re.In the operative report, there is no lot number for the prosthesis.It is written: [.Placement of an aequalis reverse baseplate (tornier laboratory) on the asymmetric graft which positioned posterosuperior, size 29 mm, long stud, stabilized by 4 screws].4 months after fitting, infection of the prosthesis requiring repeat surgery.2nd hospitalization at hospital, as the aphm surgeon left the nord debit site in october 2023 for this establishment." scar swelling and pain.It was decided to operate: a voluminous purulent subcutaneous collection with sampling for bacteriological examination.Opening of the deltopectoral fold: hematic appearance contact with the prosthesis.A new sample was taken.Prosthesis dislocation.Removal of polyethylene insert and humeral plate.Washing.Installation of a new plate for the ascend flex prosthesis, tornier laboratory.Start of immediate postoperative probabilistic antibiotic therapy tazocilline + zyvoxid.After 10 days, change of antibiotic therapy: 7 g amoxiciline per day with follow-up infectiologist for 1 year.Today, the 79-year-old patient suffers from pain + side effects of antibiotic treatment antibiotic treatment.".

• Brand Name: UNKNOWN AEQUALIS REVERSED II SPHERE
• Type of Device: SHOULDER PROSTHESIS, REVERSE CONFIGURATION
• Manufacturer (Section D): TORNIER S.A.S.; 161 rue lavoisier; montbonnot saint-martin 38330 ; FR 38330
• Manufacturer (Section G): TORNIER S.A.S.; 161 rue lavoisier; montbonnot saint-martin 38330 ; FR 38330
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 18520550
• MDR Text Key: 332974367
• Report Number: 3000931034-2024-00010
• Device Sequence Number: 1
• Product Code: PHX
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 03/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/16/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: UNK_WTM
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/28/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention