MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 OSSEOTI 4 HOLE SHELL 54MM F; PROTHESIS, HIP

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Extraskeletal ossification (1428); Pain (1994)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10: cat# 0101012366 lot# 3133587 cocr head, m, 㸠36/0, taper 12/14, cat# 290039090 lot# 3139106 clsâ spotornoâ, stem,135â°, uncemented, 9.0, taper 12/14, cat# 20103606 lot# 65627100 g7 longevity neutral 36mm f.G2: foreign: country: sweden.Product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that the patient had a left total hip arthroplasty approximately one year and three months ago.Subsequently, approximately 2-3 months post-op, the patient began to experience left severe groin pain, and at the 1-year follow-up, radiographic imaging displayed femoral heterotopic ossification.The patient is awaiting a ct scan.All implants currently remain in place.Attempts have been made, and no further information has been provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
Additional information received.It was reported that the patient¿s ossification site was seen on pre-operative images and the patient has been through the course of radiographic imaging, including a recent ct scan completed approximately two months ago.It was reported that there was no trauma or other specific contributing factors which could explain the symptoms.Patient was described as a healthy, fully compliant person with good motivation and focus on postop rehabilitation.The patient has a normal activity level and regular contact with physio.The patient is now scheduled to have an ultrasound guided injection at the ossification site for diagnostic purposes.It was reported that no further information is available.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4; b5; g3; h2; h3; h6.Product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
Additional information received that the patient had a sonography-controlled injection of local anesthetic and corticoid at the site of ossification.Attempts have been made, and no further information has been provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4;g3;h2;h3;h6.No product was returned, or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history record identified no deviations or anomalies during manufacturing.The reported products were reviewed for compatibility with no issues noted.Radiographs were provided.The images contained circled points where the site was found within pre-operative and post-operative x-rays.A medical timeline was created using the records provided and identified the following: the patient had an initial left total hip arthroscopy approximately one year and seven months ago.Subsequently, after 2-3 months post-operative, the patient began experiencing severe groin pain.At 6 weeks post operative, the patient reported mild to moderate pain, and x-rays showed no significant findings.During the 1-year follow-up, the radiographic images displayed femoral heterotopic ossification.The heterotopic ossification and a small ossificate within the medial femoris is a pre-existing condition and further diagnostic testing were being performed to rule out the cause of pain.No other trauma or contributing factors were reported, and the patient has a normal activity level.Patient was scheduled for sonography-controlled injection of anesthetics in the site of ossificate.A definitive root cause cannot be determined.Based on the provided medical records, the complaint is confirmed.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.
Event or Problem Description
No further event information is available at the time of this report.

• Brand Name: G7 OSSEOTI 4 HOLE SHELL 54MM 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: 21154859
• Report Number: 0001825034-2025-00149
• Device Sequence Number: 18414145
• Product Code: LPH
• UDI-Device Identifier: 00880304544208
• UDI-Public: (01)00880304544208(17)330313(10)7459648
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: K140669
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• 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,Followup,Followup
• Report Date (Section B): 05/14/2025

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: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 110010245
• Device Lot Number: 7459648
• 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: 01/07/2025
• Supplement Date Received by Manufacturer: 02/10/2025; 03/04/2025; 05/08/2025
• Initial Report FDA Received Date: 01/14/2025
• Supplement Report FDA Received Date: 02/26/2025; 03/20/2025; 05/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/13/2023
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female
• Patient Weight: 75 KG