MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 PPS LTD ACET SHELL 54F; PROTHESIS, HIP

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Inflammation (1932); Muscle Weakness/Atrophy (1967); Pain (1994); Loss of Range of Motion (2032); Hot Flashes/Flushes (2153); Ambulation or Postural Difficulties (2544); Cognitive Changes (2551); Syncope/Fainting (4411); Swelling/ Edema (4577)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient had a left total hip arthroplasty approximately 1.5 years ago.Right after surgery, the patient reportedly experienced cognitive decline and constant syncope with the feeling that something felt off and weird.Since surgery, the patient is having a constant burning pain, warmth to thigh, and a hot spot to bursa area.Additionally, the patient is experiencing difficulty with ambulation, and went from a cane to a walker, and now a wheelchair.The patient also reported inflammation in the body and the development of degenerative disc disease since surgery.The patient has been treated with pain medication and nerve ablation.It was reported that the patient will have metal allergy testing completed in the near future.No additional information available.
Additional Manufacturer Narrative
(b)(4).D10: cat# 650-0662, delta ceramic fem hd 36/+3mm.Cat# 51-104110, tprlc 133 t1 pps ho 11x142mm.Cat# 30103606, 36mm i.D.Size f neutral liner.Product remains implanted and 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.Multiple mdr reports were filed for this event, please see associated report: 0001825034-2024-00408.
Event or Problem Description
Additional information received.It was reported that the patient also experienced muscle atrophy, effusion, stiffness, abnormal gait, decreased rom with severe femoral internal rotation, popping sensation with grinding, and decreased stability that required extra physical therapy.No additional information.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
No further event information is available at the time of this report.
Additional Manufacturer Narrative
No product was returned, or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.The reported products were reviewed for compatibility with no issues noted.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: an initial left total hip arthroscopy was performed with no complications noted.Approximately four years later, the patient began reporting instability, difficulty ambulating, stiffness, and pain.The patient started physical therapy and noted some improvements; however, still has pain and additional symptoms.The lab test for titanium came back negative.A revision has not yet occurred.A definitive root cause cannot be determined.The reported complaint was confirmed based on the provided medical records.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 PPS LTD ACET SHELL 54F
• 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: 18721073
• Report Number: 0001825034-2024-00407
• Device Sequence Number: 20268927
• Product Code: PBI
• UDI-Device Identifier: 00880304524231
• UDI-Public: (01)00880304524231(17)310617(10)7045233
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: K121874
• 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: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/15/2024

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: 010000664
• Device Lot Number: 7045233
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/08/2024
• Supplement Date Received by Manufacturer: 02/26/2024; 07/12/2024
• Initial Report FDA Received Date: 02/16/2024
• Supplement Report FDA Received Date: 03/04/2024; 07/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/17/2021
• 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: N/A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female
• Patient Weight: 79 KG
• Patient Race: White