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 Code	Migration (4003)
Health Effect - Clinical Codes	Pain (1994); Numbness (2415); Muscle/Tendon Damage (4532)
Date of Event	05/09/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that in 2019, the patient received a right shoulder replacement with a tornier aequalis ascend implant and experienced pain and numbness in her shoulder, arm, and hand afterward.Although x-rays taken showed no issues, her pain worsened, limiting arm movement.In 2024, she underwent a reverse shoulder replacement after discovering that a part of the implant had come loose, damaging the rotator cuff and causing shoulder separation.The surgeon found that the loose piece was "chewed up," creating severe scar tissue, with the polyethylene glenoid reported as grossly loose, causing a central cavitary defect.The stem was retained, while other components were discarded.The patient had a left shoulder replacement in 2015 with no complications.
Additional Manufacturer Narrative
Based on the available information the device will not be returned therefore an evaluation of the device cannot be performed.A review of the device history is not possible because the lot number was not communicated.Should additional information become available, it will be provided in a supplemental report.
Additional Manufacturer Narrative
Correction to fda registration number from 0001649390 - te (blooming) to 3000931034 - te (mtbonnot), d3, g1, d2a, d2b, and h6 ( method code).The reported event could not be confirmed since the device was not returned for evaluation and no other evidences were provided.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.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.Indications of material, manufacturing, or design related problems were unable to be identified as the catalog number and lot number were not communicated.If the device is returned or if any additional information is provided, the investigation will be reassessed.
Event or Problem Description
It was reported that in 2019, the patient received a right shoulder replacement with a tornier aequalis ascend implant and experienced pain and numbness in her shoulder, arm, and hand afterward.Although x-rays taken showed no issues, her pain worsened, limiting arm movement.In 2024, she underwent a reverse shoulder replacement after discovering that a part of the implant had come loose, damaging the rotator cuff and causing shoulder separation.The surgeon found that the loose piece was "chewed up," creating severe scar tissue, with the polyethylene glenoid reported as grossly loose, causing a central cavitary defect.The stem was retained, while other components were discarded.The patient had a left shoulder replacement in 2015 with no complications.

• 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 MN 38330 ; FR 38330
• Manufacturer (Section G): TORNIER S.A.S.; 161 rue lavoisier; montbonnot saint-martin MN 38330 ; FR 38330
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 20081306
• Report Number: 0001649390-2024-00404
• Device Sequence Number: 7580639
• Product Code: KWS
• UDI-Device Identifier: 03700434021165
• UDI-Public: 03700434021165
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K111902
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/09/2024

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?: Yes
• 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: 07/31/2024
• Supplement Date Received by Manufacturer: 11/12/2024
• Initial Report FDA Received Date: 08/27/2024
• Supplement Report FDA Received Date: 12/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: 63 YR
• Patient Sex: Female
• Patient Weight: 76 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White