MAUDE Adverse Event Report: TORNIER S.A.S. PERFORM HUMERAL STEM SZ 2 PLUS LONG; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER + ADDITIVE, CEMENTED

Model Number DWX2PL

Device Problems Inadequacy of Device Shape and/or Size (1583); Migration (4003)

Patient Problems Fall (1848); Bone Fracture(s) (1870); Subluxation (4525)

Event Date 02/23/2023

Event Type  Injury  

Manufacturer Narrative

Device will not be returned.If additional information becomes available, it will be provided on a supplemental report.The device has been discarded by the facility.

Event Description

It was reported that a patient had a reverse shoulder arthroplasty.Patient was having some subsidence of the stem at their 1.5 week follow-up visit.Patient fell at 4 weeks post-op, pushing the stem down further and causing a fracture of the tuberosities.The problem appeared to be with an undersized implant.This caused some asymptomatic subsidence post-operatively.The patient fell at 4 weeks post-operatively.It is unknown if the size of the humeral stem had any impact on the fracture caused by the fall.The stem was removed and a 3+ long was cemented in the patient.As far as i know, yes.The fall complicated matters.The implant was initially used for a standard reverse shoulder arthroplasty.The fracture occurred approximately 4 weeks after the primary surgery.This fracture would be considered an a1.

Event Description

It was reported that a patient had a reverse shoulder arthroplasty.Patient was having some subsidence of the stem at their 1.5 week follow-up visit.Patient fell at 4 weeks post-op, pushing the stem down further and causing a fracture of the tuberosities.The problem appeared to be with an undersized implant.This caused some asymptomatic subsidence post-operatively.The patient fell at 4 weeks post-operatively.It is unknown if the size of the humeral stem had any impact on the fracture caused by the fall.The stem was removed and a 3+ long was cemented in the patient.As far as i know, yes.The fall complicated matters.The implant was initially used for a standard reverse shoulder arthroplasty.The fracture occurred approximately 4 weeks after the primary surgery.This fracture would be considered an a1.

Manufacturer Narrative

Please note the corrections made to the clinical signs code and the health impact code: the reported event was confirmed since x-rays were provided for evaluation.A review of the x-rays by the medical expert confirms ¿marked subsidence¿ of the implant prothesis in the humerus ¿over about 0.5 inches (estimated from the size of the base plate, and assuming it was placed flush with the humeral cut initially).¿ the opinion of the medical expert was requested and stated as following: ¿the stem is probably undersized.In combination with the low placement of the lateralized baseplate and an a-centric glenosphere providing more distalization, these factors play most likely a role in the event.Therefore, i conclude this event happened because a combination of two factors: a user-related (undersizing of the implant) and a patient-related factor (bone quality, and later a traumatic event causing a periprosthetic fracture and the clinical need for revision).¿ 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 (use of undersized components and low placement of the baseplate), patient-related (poor bone quality and subsequently falling on the implant side) or a combination of factors.If any additional information is provided, the investigation will be reassessed.

• Brand Name: PERFORM HUMERAL STEM SZ 2 PLUS LONG
• Type of Device: PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER + ADDITIVE, CEMENTED
• Manufacturer (Section D): TORNIER S.A.S.; 161 rue lavoisier; montbonnot saint-martin 38330 ; FR 38330
• Manufacturer (Section G): WRIGHT MEDICAL CORK (TORNIER ORTHOPEDICS IRELAND LTD); harnetts cross; macroom, co. cork NA ; EI NA
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 16597569
• MDR Text Key: 311832145
• Report Number: 3000931034-2023-00069
• Device Sequence Number: 1
• Product Code: PAO
• UDI-Device Identifier: 00846832085415
• UDI-Public: 00846832085415
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K201315
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: DWX2PL
• Device Catalogue Number: DWX2PL
• Device Lot Number: AE9767007
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/24/2023
• 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
• Patient Age: 76 YR
• Patient Sex: Male