MAUDE Adverse Event Report: TORNIER INC AFFINITI PEGGED GLENOID SZ 52; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number	0020063
Medical Device Problem Codes	Device Dislodged or Dislocated (2923); Osseointegration Problem (3003)
Health Effect - Clinical Codes	Inadequate Osseointegration (2646); Subluxation (4525)
Date of Event	11/07/2024
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
It was reported by the doctor that the patient had a failed posterior cuff in the years following the initial surgery causing posterior humeral subluxation.This caused the glenoid component to loosen over time and eventually dislodge from the glenoid.
Additional Manufacturer Narrative
Correction to d4(lot # and gtin), g1(reporting contact), and h6(method code).The reported event could not be confirmed since the device was not returned for evaluation and very limited information about the case was provided.An evaluation of the provided x-rays and medical expert opinion concluded the following: the x-rays confirm the rotator cuff insufficiency and the subluxation of the humerus in relation to the glenoid.The metal marker of the polyethylene glenoid component looks to be in a good position, however, since no comparison to early postoperative image is possible, a definitive assessment on glenoid migration cannot be made.The humeral component is still well fixated to the humeral bone.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 for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.If the device is returned or if any additional information is provided, the investigation will be reassessed.
Event or Problem Description
It was reported by the doctor that the patient had a failed posterior cuff in the years following the initial surgery causing posterior humeral subluxation.This caused the glenoid component to loosen over time and eventually dislodge from the glenoid.

• Brand Name: AFFINITI PEGGED GLENOID SZ 52
• Common Device Name: PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER 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: cécile lefeuvre ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 21242135
• Report Number: 0001649390-2025-00044
• Device Sequence Number: 3688516
• Product Code: KWS
• UDI-Device Identifier: 00846832002153
• UDI-Public: (01)00846832002153(10)CZ0214010
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K060988
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/01/2025

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: 03/28/2021
• Device Catalogue Number: 0020063
• Device Lot Number: CZ0214
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/30/2024
• Supplement Date Received by Manufacturer: 04/04/2025
• Initial Report FDA Received Date: 01/27/2025
• Supplement Report FDA Received Date: 05/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/28/2014
• 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: 65 YR
• Patient Sex: Male