MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 PPS LTD ACET SHELL 50D; PROSTHESIS, HIP

Catalog Number 010000662

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Inflammation (1932); Pain (1994)

Event Date 08/10/2022

Event Type  Injury  

Event Description

It was reported a patient was diagnosed with tendinitis and bursitis approximately six months post implantation and again at twenty months post implantation.The patient was experiencing pain and inflammation and was prescribed medication.The patient has since recovered and his happy with the outcome.Attempts have been made and no further information is available.

Manufacturer Narrative

(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2024-00723.0001822565-2024-00917.0001822565-2024-00918.D10: cat #: 51-101050 / tprlc 133 fp type1 pps ho 5.0 / lot #: 3799117.Cat #: 30103204 / g7 vit e neutral lnr 32mm d / lot #: 64922381.Cat #: 00625006525 / bone scr 6.5x25 self-tap / lot #: j7053823.Cat #: 650-1162 / delta cer fem hd 32/0mm t1 / lot #: 3084053.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch will be submitted.

Event Description

No further event information is available at the time of this report.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated: b4;d4;g3;h2;h3;h4;h6.Tendonitis is the inflammation or irritation of the tendons and is typically caused by repetitive motion, overuse, and pressure to the bursae.Symptoms the patient can experience are pain, tenderness, swelling, stiffness, decrease in movement, and/or redness at or around the joint that is involved.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 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.Tendonitis and bursitis can impact the patients¿ ability to use the joint to their full potential.The patient can experience a decrease with overall activities of daily living (adls), range of motion (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 tendonitis and bursitis can consist of, otc medications, such as tylenol and anti-inflammatories, prescribed pain medications, physical therapy, rest, ice, elevating the affected joint, and steroid injections.The root cause of the reported event was determined to be unrelated to the implanted zimmer biomet device; therefore, a review of the device history records was not performed.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 50D
• Type of Device: PROSTHESIS, 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: 18939179
• MDR Text Key: 338070599
• Report Number: 0001825034-2024-00722
• Device Sequence Number: 1
• Product Code: PBI
• UDI-Device Identifier: 00880304
• UDI-Public: (01)00880304(17)310722(10)7067118
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121874
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 010000662
• Device Lot Number: 7067118
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/21/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/22/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: SEE H10 NARRATIVE
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 46 YR
• Patient Sex: Female
• Patient Weight: 74 KG
• Patient Race: White