MAUDE Adverse Event Report: ZIMMER BIOMET, INC. FEMORAL STEM PRESS-FIT COLLARLESS 12/14 NECK TAPER STANDARD BODY; PROSTHESIS, HIP

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Inflammation (1932)
Date of Event	08/29/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported patient needed a cortisone injection approximately 1-year post implantation for trochanteric bursitis.No additional information on the reported is unavailable at this time.
Additional Manufacturer Narrative
(b)(4).Concomitant medical products: 110010262-g7, osseoti multihole 48mm, c-7030865.30123203-g7, vit e high wall lnr 32mm, c-65056193.00877503201, bioloxâ® delta, ceramic femoral head, s, 㸠32/-3.5, taper 12/14, 3043613.00625006530, bone scr 6.5x30 self-tap, j6932941.00625006535, bone scr 6.5x35 self-tap, j6840203.Bursitis is the inflammation or irritation of the bursa (the fluid filled sac that cushions the joint) and is typically caused by repetitive motion, overuse and pressure to the bursa.Bursitis is a very common condition that can impact any of the joints and can last for short duration to years.Bursitis cause can be unknown, but some common conditions that can lead to bursitis, not all inclusive; autoimmune disorders such as rheumatoid arthritis, infection, arthritis, trauma, diabetes, thyroid disease, joint surgery or joint implants, along with different medications.Symptoms the patient can experience, pain, tenderness, swelling, stiffness, decrease in movement, and/or redness at or around the joint that is involved.Bursitis is more common in women, middle aged adults and the elderly.This can impact the patients¿ ability to use the joint to their full potential.Patient can experience a decrease with overall adls, rom of the joint, decrease in quality of life, as well as increasing the need for possible over the counter (otc) medications for swelling and pain control.Treatment for bursitis can consist of, otc medications, such as tylenol and anti-inflammatories, prescribed pain medications, physical therapy, arthroscopy of the joint, rest, ice, elevating the affected joint and steroid injections.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: FEMORAL STEM PRESS-FIT COLLARLESS 12/14 NECK TAPER STANDARD BODY
• Common Device Name: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 15598932
• Report Number: 0001822565-2022-02931
• Device Sequence Number: 2265797
• Product Code: JDI
• UDI-Device Identifier: 00889024139268
• UDI-Public: (01)00889024139268(17)310825(10)64975616
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K200823
• 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: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/13/2022

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: 00786401320
• Device Lot Number: 64975616
• 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: 09/22/2022
• Initial Report FDA Received Date: 10/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/30/2021
• 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: NI
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 46 YR
• Patient Sex: Female
• Patient Weight: 194 LB
• Patient Race: White