MAUDE Adverse Event Report: TORNIER S.A.S. TORNIER PERFORM ANATOMIC GLENOID CORTILOC PEGGED S35; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number	DWE402
Medical Device Problem Codes	Device Dislodged or Dislocated (2923); Migration (4003)
Health Effect - Clinical Codes	Fall (1848); Implant Pain (4561)
Date of Event	09/27/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported: "revision case of a total anatomic to a reverse shoulder.Implants removed humeral head and glenoid pegged implant.The patient had a big fall and then after that, the glenoid implant loosened and patient needed revision surgery due to her muscles failing." the glenoid implant had completely loosened and was no longer in the correct spot.It was floating loose on the patients joint and she had pain and hence needed the revision surgery.".
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Additional Manufacturer Narrative
Please note correction to d9/h3.The reported event could not be confirmed since the device was not returned for evaluation and no other evidences were provided.A device inspection was not possible since the affected device was not returned for investigation.A review of the device history was not possible because the lot number was not communicated.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.The labeling states that: "warnings and cautions: the following situations threaten the success of the shoulder replacement implant: sport activity or high activity level, people likely to fall, alcoholism or drug abuse, inability of the patient to follow the surgeon¿s recommendations and the physical therapy program".Indications of material, manufacturing, or design related problems were unable to be identified as the lot number was not communicated.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 the device is returned or if any additional information is provided, the investigation will be reassessed.H3 other text : device disposition unknown.
Event or Problem Description
As reported: "revision case of a total anatomic to a reverse shoulder.Implants removed humeral head and glenoid pegged implant.The patient had a big fall and then after that, the glenoid implant loosened and patient needed revision surgery due to her muscles failing." the glenoid implant had completely loosened and was no longer in the correct spot.It was floating loose on the patients joint and she had pain and hence needed the revision surgery.".

• Brand Name: TORNIER PERFORM ANATOMIC GLENOID CORTILOC PEGGED S35
• Common Device Name: PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
• Manufacturer (Section D): TORNIER S.A.S.; 161 rue lavoisier; montbonnot saint-martin 38330 ; FR 38330
• Manufacturer (Section G): TORNIER S.A.S.; 161 rue lavoisier; montbonnot saint-martin 38330 ; FR 38330
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 17990684
• Report Number: 3000931034-2023-00369
• Device Sequence Number: 15520945
• Product Code: KWS
• UDI-Device Identifier: 03700434021165
• UDI-Public: 03700434021165
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K111902
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/28/2023

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: DWE402
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/27/2023
• Supplement Date Received by Manufacturer: 11/30/2023
• Initial Report FDA Received Date: 10/23/2023
• Supplement Report FDA Received Date: 12/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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