MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SMARTSET HV 20G; BONE CEMENT : BONE CEMENT

Model Number	3092-020
Medical Device Problem Code	Loss of or Failure to Bond (1068)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/13/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint #: (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
The patient was revised to address loosening of the glenoid at the cement to implant interface.Depuy cement was used.The surgeon found the keeled glenoid floating around inside the joint and removed it.Upon examining the other implants, it was determined that the patient had a functioning hemi arthroplasty so the surgeon left all the implants as they were all fixed.Doi: (b)(6) 2015, dor: (b)(6) 2021, left shoulder.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary = > no device associated with this report was received for examination.Depuy synthes considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.Device history lot = > device history reviewed: 8035590 0 non-conformances on this lot number.Final micro and sterility tests passed.All qc release specifications met.1360 units released.

• Brand Name: SMARTSET HV 20G
• Common Device Name: BONE CEMENT : BONE CEMENT
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 11891557
• Report Number: 1818910-2021-11328
• Device Sequence Number: 1389965
• Product Code: LOD
• UDI-Device Identifier: 10603295168324
• UDI-Public: 10603295168324
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K023012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/13/2021

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: Health Professional
• Device Model Number: 3092-020
• Device Catalogue Number: 3092020
• Device Lot Number: 8035590
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/13/2021
• Supplement Date Received by Manufacturer: 07/13/2021
• Initial Report FDA Received Date: 05/26/2021
• Supplement Report FDA Received Date: 07/13/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CROSSLINK FIN GLENOID 44; GLOBAL UNITE HEAD 48X18 ECC; SMARTSET HV 20G
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 71 YR