MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ARCOS 16X150MM SPL TPR DIST; PROSTHESIS, HIP

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	08/18/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Concomitant medical products: 650-1157 ¿ delta ceramic head ¿ 2020021127.Report source united kingdom.Customer has indicated that the product will not be returned to zimmer biomet for the investigation as the device remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2022 - 02239; 0001825034 - 2022 - 02240; 0001825034 - 2022 - 02241; 0001825034 - 2022 - 02242.
Event or Problem Description
It was reported that patient is experiencing excruciating pain at several follow ups after total hip arthroplasty.The patient was treated with analgesia and the pain has since resolved.The devices remain implanted.Attempts have been made and additional information on the reported event is unavailable at this time.
Event or Problem Description
No additional event information to report at this time.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated/corrected updated: d4; e1; e3; g3; h2; h3; h4; h6 the medical report indicated the patient sought medical care by going to the doctor's office for moderate pain, received prescription for pain medicine along with otc medicine approximately 6 weeks post revision procedure.This is a normal finding for 6 weeks post op total hip revision.Assessment of pain needs to be multifaceted as it is a subjective experience to each individual.Pain is a sensory symptom which provides a signal to the individual a possible underlying process may be taking place.The process may be benign, psychological or biological.Pain is a normal anticipated finding during the postoperative recovery as the wound, muscles and tissue heal and as the new joint implant is being used.The reported pain at approximately 6 weeks post revision procedure would not be considered an abnormal finding.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: ARCOS 16X150MM SPL TPR DIST
• Common Device Name: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 15510527
• Report Number: 0001825034-2022-02243
• Device Sequence Number: 20294473
• Product Code: KWA
• UDI-Device Identifier: 00880304474239
• UDI-Public: (01)00880304474239(17)301102(10)932580
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K090757
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/08/2022

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?: No
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 11-300816
• Device Lot Number: 932580
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/07/2022
• Supplement Date Received by Manufacturer: 12/07/2022
• Initial Report FDA Received Date: 09/30/2022
• Supplement Report FDA Received Date: 12/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/02/2020
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10
• Outcome Attributed to Adverse Event: Other
• Patient Age: 72 YR
• Patient Sex: Female
• Patient Weight: 60 KG