MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TRABECULAR METAL FEMORAL STEM STANDARD BODY EXTENDED NECK OFFSET SZ14 149MM; PROTHESIS, HIP

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bursitis (4832)
Date of Event	03/27/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that approximately 2 years post implantation of a left total hip arthroplasty, the patient received a cortisone injection for mild pain in the troch bursa, which relieved the pain.The surgeon reported that trochanteric bursitis is extremely common after hip replacement and is not considered a complication.There were no precedent factors for this patient other than normal everyday use of the hip.No additional information available.
Additional Manufacturer Narrative
(b)(4).D10: cat# 110010266 lot# 65077091 g7 osseoti multihole 56mm f; cat# 00625006540 lot# j6793100 bone scr 6.5x40 self-tap; cat# 00625006535 lot# j7214197 bone scr 6.5x35 self-tap; cat# 20123606 lot# 65357680 g7 longevity high wall 36mm f; cat# 00877503602 lot# 3093820 biolox⮠delta, ceramic femoral head, m, 㸠36/0, taper 12/14.Bursitis is the inflammation or irritation of the bursae (the fluid filled sac that cushions the joint) and is typically caused by repetitive motion, overuse, and pressure to the bursae.Bursitis is a very common condition that can impact any of the joints and can last for a short duration or years.Symptoms the patient can experience include pain, tenderness, swelling, stiffness, decrease in movement, and/or redness at or around the joint that is involved.Conservative treatment consists of over the counter (otc) medications pain relievers and anti-inflammatories, rest, ice, elevation, and applying pressure wraps.If conservative treatments fail, physical therapy, aspiration, arthroscopy, or steroid injections may be necessary.The complaint indicates that postop bursitis developed and required medical intervention for treatment.The root cause of the reported event was determined to be unrelated to the implanted zimmer biomet device; the reported event (bursitis) is a procedure related complication and not device related; therefore, a review of the device history records was not performed.Product remains implanted and will not be returned to zimmer biomet for investigation.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: TRABECULAR METAL FEMORAL STEM STANDARD BODY EXTENDED NECK OFFSET SZ14 149MM
• Common Device Name: PROTHESIS, 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: 19105114
• Report Number: 0001822565-2024-01164
• Device Sequence Number: 7840197
• Product Code: LPH
• UDI-Device Identifier: 00889024139282
• UDI-Public: (01)00889024139282(17)320410(10)65353401
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K051491
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• 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): 04/15/2024

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: 00786401420
• Device Lot Number: 65353401
• 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: 03/28/2024
• Initial Report FDA Received Date: 04/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/18/2022
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male
• Patient Weight: 124 KG
• Patient Race: White