MAUDE Adverse Event Report: TORNIER S.A.S AEQUALIS REVERSED FRACTURE; PROSTHESIS SHOULDER METAL

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pulmonary Embolism (1498); Hematoma (1884)

Event Date 12/31/2019

Event Type  Injury  

Manufacturer Narrative

On november 10st, 2020 stryker trauma and extremities acquired tornier sas.An effort was made to align the acquired entity complaint files with stryker's policies and procedures.Stryker has performed retrospective review of complaints and the reportability decision was revised to report this incident under the mdr process.The reported event could not be confirmed since the device was not returned for evaluation and no other evidences were provided.A review of the device history was not possible because the lot number was not communicated.No corrective actions are required at this time.Incidence of hematoma alone, although relatively common, does not affect the overall outcome of reversed total shoulder arthroplasty.No specific risk factor could be associated with development of hematoma, proper placement of the implant is necessary to avoid fluid collection in empty areas or what are called dead spaces.The pulmonary embolism is a complication not specific to the device, but which could occur following a surgical act.At the last follow-up, no other complication was recorded: no prosthetic instability, infection or implant loosening was encountered, and no patients required further surgery.Based on the low available information, there is no evidence that this case is related to the device, root cause cannot be clearly determined.

Event Description

From literature "reverse shoulder arthroplasty for acute fractures in the elderly: is it worth reattaching the tuberosities?" boileau p et al., jses, 2019, 28:437-444.Two temporary early postoperative complications occurred, and both were treated medically: 1 patient had a hematoma along the upper limb, and another had a pulmonary embolism.

• Brand Name: AEQUALIS REVERSED FRACTURE
• Type of Device: PROSTHESIS SHOULDER METAL
• Manufacturer (Section D): TORNIER S.A.S; 161 rue lavoisier; montbonnot saint martin, ; FR
• Manufacturer Contact: laurent ray ; 161 rue lavoisier; montbonnot saint martin ; FR
• MDR Report Key: 13606786
• MDR Text Key: 286346467
• Report Number: 3000931034-2022-00101
• Device Sequence Number: 1
• Product Code: KWS
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K082120
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/31/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/25/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/31/2019
• 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): Other