MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 PPS LTD ACET SHELL 46B; PROSTHESIS, HIP

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Inflammation (1932); Pain (1994)
Date of Event	11/11/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2023-01732 and 0001825034-2023-01734.D10: cat# 12-115116, lot# 2970965, cer bioloxd mod hd 32mm +3 nk.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.
Event or Problem Description
It was reported that the patient underwent an initial right total hip arthroplasty.Subsequently, at approximately eight months post-op the patient developed persistent lateral thigh and groin pain.Tendonitis was suspected however, the surgeon also questioned if there was an issue with the press-fit femoral component.Approximately 9 months post-op, an injection of steroids and local anesthetic was given under fluoroscopic guidance.The patient has since completed the study with improvement in pain and all implants remaining in place.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
Tendinitis is inflammation of a tendon that attaches muscle to bone.It can happen to any tendon in the body.When a tendon is inflamed, it can cause swelling, pain, and discomfort.Tendinitis often results from sports injuries or repetitive movements, it's usually caused by overuse.The condition is more common in adults over the age of 40 and athletes.With tha the hip is manipulated and tendons get stretched and pulled which can cause it to be inflamed with symptoms of swelling, pain, and discomfort.As the patient is recovering tendonitis can develop from overuse, especially within the first couple months.Tendinitis may go away over time.If not, a doctor will recommend treatments to reduce pain and inflammation and preserve mobility.Most cases of tendonitis can be successfully treated with rest, ice, compression (a sleeve or wrap), elevation, stretching, and modification of activities however tendinitis is also commonly treated with steroid injections to reduce the pain and inflammation.When properly treated, most tendinitis conditions don¿t result in permanent joint damage or disability.The best way to prevent it from occurring is to avoid or modify activities that caused the problem.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 information at the time of this report.

• Brand Name: G7 PPS LTD ACET SHELL 46B
• Common Device Name: 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: 17388225
• Report Number: 0001825034-2023-01733
• Device Sequence Number: 6302745
• Product Code: PBI
• UDI-Device Identifier: 00880304524194
• UDI-Public: (01)00880304524194(17)290702(10)6575360
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K121874
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/08/2023

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: 010000660
• Device Lot Number: 6575360
• 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: 07/03/2023
• Supplement Date Received by Manufacturer: 11/07/2023
• Initial Report FDA Received Date: 07/25/2023
• Supplement Report FDA Received Date: 11/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/31/2019
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10 NARRATIVE.
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female
• Patient Weight: 97 KG
• Patient Race: White