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

Model Number N/A

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

Patient Problems Pain (1994); Limited Mobility Of The Implanted Joint (2671)

Event Date 01/31/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: catalog number: 010000662 lot number:3959139 brand name: g7 acetabular shell, catalog number:010000856 lot number: 3907483 brand name: g7 acetabular liner, catalog number:193108 lot number:688600 brand name: echo bimetric stem, catalog number:650-1057 lot number:613600 brand name: biolox head.Multiple mdr reports were filed for this event, please see associated reports 0001825034-2019-02632, 0001825034-2019-02631.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Device remains implanted in the patient.

Event Description

It was reported that the patient is experiencing pain decreased flexion, mobility and satisfaction approximately 2 years post implantation.Attempts have been made and additional information on the reported event is unavailable.

Manufacturer Narrative

Medical records/radiographs were provided and reviewed by a health care professional.Review of the available clinical records identified the following visit one year post implantation ¿ regularly participates in moderate activities.¿ improved eq-5d-3l form for mobility and pain/discomfort.¿ pain noted on physical exam form after walking at anterior and lateral thigh noted to be mild.¿ pain noted on harris hip score to be mild.Improved ability to don/doff socks and no limp indicated.Rom improved in abduction (in flexion),external and internal rotation (in extension).¿ radiographs unremarkable.Visit two years post implantation ¿ sometimes participates in mild activities such as walking, limited housework and limited shopping.Noted to be dissatisfied with hip replacement.¿ eq-5d-3l noted to be back to baseline measurement with noted improved with anxiety/depression.¿ pain noted on physical exam to be severe at groin, moderate at trochanter and buttock.[worsening pain with new finding of pain at buttock].¿ pain noted on harris hip score to be marked backed to preop findings.Utilizes any method for stairs.[decrease] comfortable in high chair for one-half hour.[decrease] able to walk two or three blocks.[decrease] rom: flexion 45 degrees [decrease] returned to preop measurements with abduction (in flexion) and internal rotation (in extension) with improvement noted in adduction (in flexion) and external rotation (in extension).¿ radiographs unremarkable.Reported event was confirmed by review of medical records provided.Device history record was reviewed and no discrepancies were found.Root cause was unable to 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.

Event Description

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

• Brand Name: G7 NEUTRAL E1 LINER 36MM D
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8711577
• MDR Text Key: 148405225
• Report Number: 0001825034-2019-02630
• Device Sequence Number: 1
• Product Code: PBI
• Combination Product (y/n): N
• PMA/PMN Number: K121874
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 09/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/19/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/21/2021
• Device Model Number: N/A
• Device Catalogue Number: 010000856
• Device Lot Number: 3907483
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/24/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 61 YR
• Patient Weight: 68