MAUDE Adverse Event Report: OSTEOREMEDIES, LLC REMEDY HIP; REMEDY HIP HEAD

Model Number	RHHDSM
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/23/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
Four days post-op the head of the hip implant disassociated from the stem.The disassociated head was explanted and replaced with a new head.

• Brand Name: REMEDY HIP
• Common Device Name: REMEDY HIP HEAD
• Manufacturer (Section D): OSTEOREMEDIES, LLC; 6075 poplar ave; memphis, tn 38119
• MDR Report Key: 11797384
• Report Number: 3010537287-2021-00004
• Device Sequence Number: 4492409
• Product Code: KWL
• UDI-Device Identifier: 00855195006258
• UDI-Public: 00855195006258
• Combination Product (Y/N): Y
• PMA/510(K) Number: K112470
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/07/2021

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?: No
• Operator of Device: Health Professional
• Device Model Number: RHHDSM
• Device Catalogue Number: RHHDSM
• Device Lot Number: OR01092
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/23/2021
• Initial Report FDA Received Date: 05/10/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: RHACSM REMEDY ACETABULAR CUP LOT OR01098; RHLSMD REMEDY STEM LOT OR00870
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 69 YR