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

Model Number N/A

Device Problem Noise, Audible (3273)

Patient Problems Failure of Implant (1924); Pain (1994); Osteolysis (2377); Ambulation Difficulties (2544); Foreign Body In Patient (2687)

Event Date 03/08/2023

Event Type  Injury  

Event Description

It was reported the patient underwent an initial left total hip arthroplasty that was subsequently revised approximately four (4) years later due to pain, noise, instability, osteolysis, and loosening.During the revision while placing the cage noted a screw broke and was unable to retrieve broken part.The stem was well fixed and remained implanted.The shell, liner, head, and taper sleeve were exchanged without complications.Attempts have been made and no further information has been provided.

Manufacturer Narrative

(b)(4).Concomitant medical products: cat# 650-1057 lot# 2958832 cer bioloxd option hd 36mm cat# 650-1065 lot# 2959085 cer option type 1 tpr sleve -3 cat# 00625006530 lot# 64403729 bone scr 6.5x30 self-tap cat# 010000856 lot# 6443904 g7 neutral e1 liner 36mm d no product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history record(s) identified no deviations or anomalies during manufacturing related to the reported event.Medical records/radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: x-ray found acetabular loosening superomedial breaching medial wall, ct ¿ osteolysis, acetabular protusio consistent with loosening, nondisplaced fracture of inferior medial wall, acetabular component malposition.Pain in left hip for 15 months along with clicking, instability, snapping/popping, no history of falls in last 12 months, ambulating with assistive device.Noted acetabular bone loss superior and medial.No complications, noted procedure 100% took more time due to large acetabular bone defect, need for cage and additional fixation.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 D
• 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: 16725404
• MDR Text Key: 313150732
• Report Number: 0001825034-2023-00794
• Device Sequence Number: 1
• Product Code: PBI
• UDI-Device Identifier: 00880304526419
• UDI-Public: (01)00880304526419(17)231214(10)6443904
• 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: Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/14/2023
• Device Model Number: N/A
• Device Catalogue Number: 010000856
• Device Lot Number: 6443904
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/10/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2018
• 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
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Male
• Patient Weight: 81 KG