MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 HI-WALL E1 LINER 36MM D; PROSTHESIS, HIP

Model Number N/A

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

Patient Problems Ossification (1428); Pain (1994); Loss of Range of Motion (2032); Weakness (2145)

Event Date 11/05/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: unknown head.12-151307 echo fx 7mm std femoral unknown.110010263 g7 osseoti multihole 50mm d unknown.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2019-03012, 0001825034-2019-03014, 0001825034-2019-03017.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that the patient experienced pain and weakness approximately 15 months post revision surgery.Additional information on the reported event is unavailable at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Reported event was unable to be confirmed due to limited information received from the customer.Medical records were provided and findings include: one month post-op office visit: left lower extremity weakness; mild pain; x-rays no loosening, minimal heterotopic ossification , excellent alignment; superior anterior trochanter area of tenderness ¿ injection w/kenalog & marcaine.Two months post- office visit: left lateral upper thigh pain radiating down after long periods of standing; flexion of hip improved; heterotopic bone after the revision surgery has most likely limited flexion somewhat.Three months post office visit: continues to complain of discomfort anterior left thigh down to knee and weakness left knee; unable to stand greater than couple hours, and resigned from job; no trendelenburg gait; ordered tests to rule out loosening and infection ¿ no results provided; ordered physical therapy to weakness and endurance.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.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 Description

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

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Medical records/radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: left extremity weakness, mild pain with no loosening of components and excellent alignment 1-year post-op as reported, office visits continue with prescribed pt and ongoing pain and weakness over the next 2 years, no revision at this time has been completed, latest xrays still show good alignment and fixation.The additional information does not change the outcome of the previous investigation.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 Description

It was additionally reported that the patient is experiencing ongoing pain and stiffness.However, no revision has been reported to date.No further event information available at the time of this report.

• Brand Name: G7 HI-WALL E1 LINER 36MM D
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 8791299
• MDR Text Key: 151096212
• Report Number: 0001825034-2019-03016
• 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: Other,Consumer,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 12/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 010000934
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/03/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10 NARRATIVE
• Patient Outcome(s): Hospitalization; Other
• Patient Sex: Female
• Patient Weight: 93 KG