MAUDE Adverse Event Report: TORNIER INC PERFORM HUMERAL STEM SZ 4; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER + ADDITIVE, CEMENTED

Catalog Number	DWX4SS
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Joint Dislocation (2374); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/26/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Analysis results are not available at the time of this report.A follow-up report will be sent when the analysis is complete.
Event or Problem Description
It was reported that the patient had a dislocation, possibly attributed to night terrors after the initial surgery.The patient underwent a revision surgery to replace the poly insert.During impaction of the poly it was noted that it would not seat despite repeated malleting of the implant.This caused the stem to subside as well as the poly to be damaged.The stem was removed and replaced with longer stem and a new poly was implanted.
Additional Manufacturer Narrative
Corrections: h6: device codes, clinical signs code, d9: product available to stryker.The reported event was not confirmed.Since, the device was not returned for evaluation.And no other evidences were provided.The device inspection was not possible, as the product was not returned for investigation.A review of the device history, for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.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 investigation, the root cause was attributed to a user related issue.The failure was caused by an application of excessive mechanical force, during surgery.If device is returned or any further information is provided, the investigation report will be reassessed.
Event or Problem Description
It was reported, that the patient had a dislocation.Possibly, attributed to night terrors after the initial surgery.The patient, underwent a revision surgery to replace the poly insert.During, impaction of the poly it was noted, that it would not seat, despite repeated malleting of the implant.This caused the stem to subside.As well as, the poly to be damaged.The stem was removed and replaced with longer stem and a new poly was implanted.

• Brand Name: PERFORM HUMERAL STEM SZ 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): 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: 19140553
• Report Number: 0001649390-2024-00175
• Device Sequence Number: 17975630
• Product Code: PAO
• UDI-Device Identifier: 00846832085514
• UDI-Public: 00846832085514
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K201315
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/18/2024

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 Catalogue Number: DWX4SS
• Device Lot Number: AG3859
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 04/04/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 06/26/2024
• Initial Report FDA Received Date: 04/18/2024
• Supplement Report FDA Received Date: 07/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/27/2023
• 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