MAUDE Adverse Event Report: TORNIER INC AFFINITI STANDARD HUMERAL HEAD DIA 56 MM THICKNESS 18 MM; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number	0020057
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Implant Pain (4561)
Date of Event	07/12/2017
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.Should additional information become available, it will be provided in a supplemental report.
Event or Problem Description
As reported: "impingement syndrome persistent symptoms localized over ac joint and along the sub acromial space.Additional information received on 31 may 2024: re-operation on (b)(6) 2017 (no component removal): 1.Arthroscopic acromioclavicular joint resection.2.Arthroscopic sub acromial decompression.Other action taken: rehabilitation/physical therapy.Resolved without sequelae on (b)(6) 2019.".
Event or Problem Description
As reported: "impingement syndrome.Persistent symptoms localized over ac joint and along the sub acromial space.Additional information received on 31 may 2024: re-operation on (b)(6) 2017 (no component removal).1.Arthroscopic acromioclavicular joint resection.2.Arthroscopic sub acromial decompression.Other action taken: rehabilitation/physical therapy.Resolved without sequelae on (b)(6) 2019.".
Additional Manufacturer Narrative
The reported event could not be 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 any further information is provided, the complaint report will be updated.

• Brand Name: AFFINITI STANDARD HUMERAL HEAD DIA 56 MM THICKNESS 18 MM
• 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: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 19607309
• Report Number: 0001649390-2024-00278
• Device Sequence Number: 20392468
• Product Code: KWS
• UDI-Device Identifier: 00846832002108
• UDI-Public: 00846832002108
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K060988
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/28/2024

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 Expiration Date: 01/31/2016
• Device Catalogue Number: 0020057
• Device Lot Number: AZ1410
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/29/2024
• Supplement Date Received by Manufacturer: 08/01/2024
• Initial Report FDA Received Date: 06/25/2024
• Supplement Report FDA Received Date: 08/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/31/2011
• 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: 75 YR
• Patient Sex: Male
• Patient Weight: 85 KG