MAUDE Adverse Event Report: TORNIER INC PERFORM HUMERAL STEM SZ 3; SHOULDER PROSTHESIS, SEMI-CONSTRAINED, METAL, CEMENTED

Catalog Number	DWX3SS
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/13/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Upon completion of the investigation, additional information will be provided in a supplemental report.
Event or Problem Description
The surgeon implanted the perform humeral #3 standard stem in the patient and while attempting to impact the 39mm + 6 reverse insert he couldn¿t successfully seat it into the stem.After several attempts it was decided to open a second reverse insert.Prior to attempting to implant the second reverse insert the humeral cut surface was inspected, trimmed & reamed to assure that there was nothing blocking the insert to seat correctly.On the second reverse implant attempt the surgeon experienced the same issues and ended up dropping the second implant to the floor.The surgeon then explanted the perform humeral stem and attempted several times to impact the reverse insert that was opened the first time on the back table with the impaction stand without success.At that time, he asked for a new perform humeral stem to be opened and reverse insert.The new perform humeral stem and insert was implanted without any problems.This whole troubleshooting process probably added 20-30 minutes to the surgical time.
Event or Problem Description
The surgeon implanted the perform humeral #3 standard stem in the patient and while attempting to impact the 39mm + 6 reverse insert he couldn¿t successfully seat it into the stem.After several attempts it was decided to open a second reverse insert.Prior to attempting to implant the second reverse insert the humeral cut surface was inspected, trimmed & reamed to assure that there was nothing blocking the insert to seat correctly.On the second reverse implant attempt the surgeon experienced the same issues and ended up dropping the second implant to the floor.The surgeon then explanted the perform humeral stem and attempted several times to impact the reverse insert that was opened the first time on the back table with the impaction stand without success.At that time, he asked for a new perform humeral stem to be opened and reverse insert.The new perform humeral stem and insert was implanted without any problems.This whole troubleshooting process probably added 20-30 minutes to the surgical time.No complementary anesthesia was given.No bone loss was experienced due to these complications.Perform humeral core tray and perform humeral stem tray was used for this surgery.
Additional Manufacturer Narrative
The reported event could be confirmed, since the device was returned for evaluation, and matches the alleged failure.The device inspection revealed the following: visual inspection a visual inspection revealed the returned stem (dwx3ss) revealed slight surface scratches which is most likely a result of the attempts to seat the poly.Overall, the stem looked to be in excellent condition.Functional inspection: per the r&d engineer, "additionally, a spare polyethylene component/ring assembly was assembled into the stem that was returned without issue.I did not insert the complaint polys because once inserted it is impossible to disassemble without destroying.The spare poly assembled without issue when following the surgical technique.The third picture shows how the poly looks post-disassembly when it was assembled fully." a review of the device history for the reported lot did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.Based on analysis of the returned component and provided information, the root cause was attributed to user related issue.The most likely cause of the reported difficulty is due to the user not applying thumb pressure to the polyethylene component prior to impaction.The surgical technique instructs the user to "apply hand pressure to begin to engage the locking mechanism." if any additional information is provided, the investigation will be reassessed.

• Brand Name: PERFORM HUMERAL STEM SZ 3
• Common Device Name: SHOULDER PROSTHESIS, SEMI-CONSTRAINED, METAL, CEMENTED
• Manufacturer (Section D): TORNIER INC; 10801 nesbitt avenue s; bloomington MN 55437
• Manufacturer (Section G): WRIGHT MEDICAL CORK (TORNIER ORTHOPEDICS IRELAND LTD); harnetts cross; macroom, co. cork NA ; EI NA
• Manufacturer Contact: janice mithouard ; 161 rue lavoisier; montbonnot saint-martin 38330 ; FR 38330 ; 476613500
• MDR Report Key: 12801932
• Report Number: 3004983210-2021-00082
• Device Sequence Number: 5548306
• Product Code: PAO
• UDI-Device Identifier: 00846832085477
• UDI-Public: 00846832085477
• Combination Product (Y/N): N
• Initial Reporter State: ME
• Initial Reporter Country: US
• PMA/510(K) Number: K201315
• 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): 02/01/2022

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: 08/21/2025
• Device Catalogue Number: DWX3SS
• Device Lot Number: AD1572
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/20/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/13/2021
• Supplement Date Received by Manufacturer: 01/07/2022
• Initial Report FDA Received Date: 11/12/2021
• Supplement Report FDA Received Date: 02/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/21/2020
• 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