MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 OSSEOTI SHELL MULTIHOLE 56MM F; PROTHESIS, HIP

Catalog Number	110010266
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Bursitis (4832)
Date of Event	08/16/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent an initial hip procedure.Subsequently, the patient reported tenderness over the greater trochanter consistent with bursitis approximately 1 year later.The patient was using canes to ambulate and experienced a moderate limp.The surgeon provided a cortisone injection and a topical anti-inflammatory cream, and the issues were reportedly resolved.Attempts have been made, and no further information has been provided.
Additional Manufacturer Narrative
(b)(4).D10: cat # 00625006525 lot # j7217788 bone screw self-tapping 6.5 mm dia.25 mm length cat # 00625006540 lot # j7240913 bone screw self-tapping 6.5 mm dia.40 mm length cat # 00786401420 lot # 63159639 femoral stem press-fit collarless 12/14 neck taper standard body extended neck offset size 14 149 mm stem length cementless cat # 20123606 lot # 65454289 36mm i.D.Size f high wall liner.Cat # 00877503603 lot # 3099852 biolox⮠delta, ceramic femoral head, l, 㸠36/+3.5, taper 12/14.The customer has indicated that the product will not be returned to zimmer biomet for investigation as it remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were {update/corrected}.Updated: e1; e2; e3; g3; h2.
Event or Problem Description
No further information at the time of this report.
Event or Problem Description
No further information at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were {update/corrected}.Updated: d4; g3; h2; h3; h4; h6.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.The device history record was not reviewed as this is a limited investigation, as per procedure, a review of the device history record and complaint history review will not be completed for limited investigation complaints as the product meets the applicable acceptance criteria.Review of the reported event by a health care professional found: 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 device.Attempts have been made to gather all product identification information, and no further information has been provided.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: G7 OSSEOTI SHELL MULTIHOLE 56MM F
• Common Device Name: PROTHESIS, 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: 22884359
• Report Number: 0001825034-2025-02669
• Device Sequence Number: 9604496
• Product Code: LPH
• UDI-Device Identifier: 00887868356049
• UDI-Public: (01)00887868356049(17)320328(10)65300751
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K140669
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/02/2025

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: Lay User/Patient
• Device Catalogue Number: 110010266
• Device Lot Number: 65300751
• 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: 07/31/2025
• Supplement Date Received by Manufacturer: 09/12/2025; 12/02/2025
• Initial Report FDA Received Date: 08/25/2025
• Supplement Report FDA Received Date: 09/30/2025; 12/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/28/2022
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11 NARRATIVE
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female
• Patient Weight: 111 KG
• Patient Race: White