MAUDE Adverse Event Report: TORNIER INC AFFINITI PEGGED GLENOID SZ 44; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Model Number	0020061
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	06/12/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device will not be returned.If additional information becomes available, it will be provided on a supplemental report.
Event or Problem Description
It was reported that the glenoid component loosened.
Additional Manufacturer Narrative
The reported event could be confirmed.X-rays were returned for evaluation and confirmed the event noted in this complaint.The device inspection was not possible as the product 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 medical opinion of a medical expert was requested to evaluate the risk of this event: after review of the tornier shout clinical report - ¿if have read the shout-form and there are no patient characteristics in there that increase the changes of shoulder arthroplasty revision as such.Loosening of the glenoid component is one of the most common reasons for revision in anatomic total shoulder arthroplasty.With uhmwpe indeed ¿polyethylene particle disease¿ plays an important role.Uhmwpe-particles of certain sizes trigger a type iv immune response that causes macrophages (cells that are trying to clear up the particles) to invade bone at the bone-(cement)-implant interface, thus causing loosening.¿ after review of provided x-rays ¿ ¿the changes in the peri-articular bone structure (both proximal humerus and glenoid show a typical moth-eaten and cystic lesions aspect), the asymmetric joint space suggesting uhmwpe-wear, make loosening because of particle disease the most likely cause.¿ if device is returned or any further information is provided, the investigation report will be reassessed.
Event or Problem Description
It was reported that the glenoid component loosened.

• Brand Name: AFFINITI PEGGED GLENOID SZ 44
• 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: nathe hendricks ; 1023 cherry rd; memphis, TN 38117 ; 9014516318
• MDR Report Key: 12298373
• Report Number: 3000931034-2021-00298
• Device Sequence Number: 4490384
• Product Code: KWS
• UDI-Device Identifier: 00846832002139
• UDI-Public: 00846832002139
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K060988
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/19/2022

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 Model Number: 0020061
• Device Catalogue Number: 0020061
• 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: 07/12/2021
• Supplement Date Received by Manufacturer: 12/23/2021
• Initial Report FDA Received Date: 08/09/2021
• Supplement Report FDA Received Date: 01/19/2022
• 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 Age: 75 YR
• Patient Sex: Female