MAUDE Adverse Event Report: TORNIER INC PERFORM HUMERAL +9MM SPACER SZ3/4; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER + ADDITIVE, CEMENTED

Model Number	DWX934
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	03/14/2023
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
The patient had a primary reverse shoulder arthoplasty around 2020/21.He had a revision for instability on (b)(6) 2021 and again on (b)(6) 2022.The patient was chopping wood and carrying the wood in his affected arm.He experienced a dislocation on (b)(6)2023.X-rays were taken at his local va and it was evident that the polyethelene liner had disassociated.The patient underwent surgery on (b)(6) 2023 to remove the old liner and spacer and replace with new items.
Event or Problem Description
The patient had a primary reverse shoulder arthoplasty around 2020/21.He had a revision for instability on (b)(6) 2021 and again on (b)(6) 2022.The patient was chopping wood and carrying the wood in his affected arm.He experienced a dislocation on (b)(6) 2023.X-rays were taken at his local va and it was evident that the polyethelene liner had disassociated.The patient underwent surgery on (b)(6) 2023 to remove the old liner and spacer and replace with new items.
Additional Manufacturer Narrative
Please note the correction statement regarding d9/h3, h6 method code: the reported event was confirmed, since the device was returned for evaluation, and matches the alleged failure.The device inspection revealed the following: a visual inspection revealed the returned implant (dwx934) has multiple surface scratches where the poly portion is inserted into the device.There are also noticeable scratches around the upper ring of the device.Additionally, significant fretting was noted on the post that mates with the humeral component of the prothesis.Functional inspection: a functional inspection of the spacer could not be performed due to the risk of damage the poly insert component would incur in order to successfully separate the spacer from the poly.A review of the labeling and 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.Since data were provided, the opinion of a medical expert was sought and stated as following: ¿knowing the patient¿s history with implant stability issues, should he be chopping wood and carrying it with his affected arm? would this be ¿non-compliance¿ on his part? patients should be informed by their hcp that a shoulder arthroplasty does not compare to a normal native shoulder joint.They should be informed that overloading (carrying weights, manual labor and certain types of sports) may influence the lifetime of the device.I conclude that chopping wood and carrying wood may jeopardize the service life of the implant.Could the event have been caused by improper technique used by the surgeon?? (again, i know this is difficult to answer due to the fact that we do not have any x-rays to review.) the patient had an unstable shoulder, meaning insufficient soft tissue tensioning and/or issues with the position of the device.The surgeon tried to solve the problem by adding polyethylene thickness (exchanged for thicker poly insert), which will cause higher stresses on the polyethylene.The damage on the pe-liner may be the result of impingement, adding more forces that may dislodge the liner.Yes, technical procedure related issues may have been a causative factor.X-rays could be helpful in that.Are there any other contributing factors for this event that i am overlooking? see the above answers.¿ based on the investigation, the root cause was attributed to a patient related complication not related to the implanted device.If any additional information is provided, the investigation will be reassessed.

• Brand Name: PERFORM HUMERAL +9MM SPACER SZ3/4
• Common Device Name: PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER + ADDITIVE, CEMENTED
• 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: 16736613
• Report Number: 0001649390-2023-00048
• Device Sequence Number: 17853335
• Product Code: PAO
• UDI-Device Identifier: 00846832085538
• UDI-Public: 00846832085538
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K201315
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/05/2023

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 Expiration Date: 09/23/2025
• Device Model Number: DWX934
• Device Catalogue Number: DWX934
• Device Lot Number: 9720AV
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/15/2023
• Supplement Date Received by Manufacturer: 06/07/2023
• Initial Report FDA Received Date: 04/13/2023
• Supplement Report FDA Received Date: 07/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/23/2020
• 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: Male