MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 NEUTRAL E1 LINER 36MM F; PROSTHESIS, HIP

Catalog Number 010000858

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

Patient Problems Pain (1994); Ambulation Difficulties (2544)

Event Date 08/30/2023

Event Type  Injury  

Event Description

It was reported during a clinical study that at the patient¿s five-year follow-up appointment, the patient was experiencing pain, difficulty with ambulation and completing daily activities; and was diagnosed with tendonitis.The patient was treated with anti-inflammatory medication, physical therapy, and a steroid injection.The issue has been considered resolved.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: 0001825034-2024-00018 and 0001825034-2024-00020.D10: cat #: 110017105 / g7 finned 4 hole shell 56f / lot #: 6215509.Cat #: 51-104110 / tprlc 133 t1 pps ho 11x142mm / lot #: 6232281.Cat #: 6501057 / cer bioloxd option hd 36mm / lot #: 2934974.Cat #: 6501064 / cer option type 1 tpr sleve -6 / lot #: 2912967.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.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated/corrected an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch will be submitted.

Event Description

It was reported during a clinical study that at the patient¿s five-year follow-up appointment, the patient was experiencing pain, difficulty with ambulation and completing daily activities; and was diagnosed with tendonitis.The patient was treated with anti-inflammatory medication, physical therapy, and a steroid injection.The issue has been considered resolved.At the three-month follow-up appointment, the patient noted temporary relief from the injection but is still experiencing pain during active flexion or activity.The patient is maintaining conservative treatment modalities and physical therapy.

Event Description

No additional event information to report at this time.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Dhr was reviewed and no discrepancies related to the reported event were found.Medical records/radiographs were provided and reviewed by a health care professional.A review of the available records identified findings of the reported issues: 1 year follow-up visit ¿ no updates recorded; visit missed by patient.3 year follow-up visit ¿ regularly participates in moderate activities, unlimited walking distance ¿ no gait issues, no problems with daily activities ¿ no supportive devices required ¿ no pain.5 year follow-up visit ¿ regularly participates in active events ¿ reports moderate pain, especially with hip flexion ¿ reports mild-moderate difficulty with activities of daily living ¿ moderate difficulty walking for extended periods and moderate trouble climbing stairs ¿ limps most of the time ¿ ae-diagnosis of tendonitis treated with nsaid, physical therapy, and cortisone injections- believed to be related to acetabular component specifically ¿ *noted that an ae was also entered for unrelated/contralateral l hip-worsening osteoarthritis ¿ documented as resolved.Approximately 5 years post op office visit ¿ patient reports bilateral hip pain 6/10, takes otc aleve as needed ¿ x-rays ¿ implants in satisfactory position without complications ¿ cortisone injections ordered for both hips for arthritis in the left and tendinitis in the right.Approximately 5 years post op office visit ¿ hip injections were ordered but not given at last appointment, still reports 7/10 pain.Approximately 5 years post op - injections ¿ injections reordered and administered approxmately 5 years - office visit ¿ patient reports that injections provided significant relief for about a week, otc and prescription anti-inflammatories further relieve pain ¿ patient has restarted formal outpatient physical therapy ¿ continues to have pain with active hip flexion which is alleviated with rest ¿ x-rays ordered to assess acetabular position but at this time, patient will continue conservative treatment, nsaids and pt, follow up in 6-8 weeks.Approximately 5 years post op - ¿ per dr.Emerson ¿related to acetabular component only¿.Complaint is confirmed via the evaluations of the provided medical records.A definitive root cause cannot be determined.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 NEUTRAL E1 LINER 36MM F
• 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: 18443821
• MDR Text Key: 331887345
• Report Number: 0001825034-2024-00019
• Device Sequence Number: 1
• Product Code: PBI
• 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,Followup
• Report Date: 04/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/03/2023
• Device Catalogue Number: 010000858
• Device Lot Number: 6292613
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/16/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/03/2018
• 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): Hospitalization; Required Intervention
• Patient Sex: Male
• Patient Weight: 98 KG
• Patient Race: Black Or African American