MAUDE Adverse Event Report: TORNIER INC PERFORM REV INSERT SZ 3/4, 39MM DIA, +3; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Catalog Number	DWP2393
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	08/10/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
During a revision surgery, larger glenosphere and poly implants were used to address chronic dislocation in the patient's shoulder joint.It's likely that the teeth of one of the instruments, specifically the glenosphere removal tool, were bent prior to the surgery, as they were observed to be slightly bent from the outset.The glenosphere and poly implants were tornier products.However, it's important to note that the revision surgery was not due to faulty implants but rather instability issues.The surgical procedure encountered difficulties initially due to the damaged instrument but proceeded smoothly after switching to another set of instruments.
Additional Manufacturer Narrative
The device will not be returned.If additional information becomes available, it will be provided in a supplemental report.
Additional Manufacturer Narrative
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.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.If device is returned or any further information is provided, the investigation report will be reassessed.
Event or Problem Description
During a revision surgery, larger glenosphere and poly implants were used to address chronic dislocation in the patient's shoulder joint.It's likely that the teeth of one of the instruments, specifically the glenosphere removal tool, were bent prior to the surgery, as they were observed to be slightly bent from the outset.The glenosphere and poly implants were tornier products.However, it's important to note that the revision surgery was not due to faulty implants but rather instability issues.The surgical procedure encountered difficulties initially due to the damaged instrument but proceeded smoothly after switching to another set of instruments.

• Brand Name: PERFORM REV INSERT SZ 3/4, 39MM DIA, +3
• Common Device Name: SHOULDER PROSTHESIS, REVERSE CONFIGURATION
• 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: 17692912
• Report Number: 0001649390-2023-00220
• Device Sequence Number: 6057467
• Product Code: PHX
• UDI-Device Identifier: 00846832084494
• UDI-Public: 00846832084494
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K201315
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/25/2023

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 Catalogue Number: DWP2393
• Device Lot Number: 8269AY
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/10/2023
• Supplement Date Received by Manufacturer: 09/28/2023
• Initial Report FDA Received Date: 09/06/2023
• Supplement Report FDA Received Date: 10/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/04/2023
• 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 Age: 84 YR
• Patient Sex: Male