MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 SCREW 6.5MM X 25MM; PROSTHESIS, HIP

Model Number N/A

Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problems Failure of Implant (1924); Insufficient Information (4580)

Event Date 11/22/2023

Event Type  Injury  

Manufacturer Narrative

(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2023 - 02972 and 0001825034 - 2023 - 02992.D10: cat# 650-0661 lot# 314468 delta ceramic fem hd 36/0mm.Cat# 010000937 lot# 7144262 g7 hi-wall e1 liner 36mm g.Cat# 010000991 lot# 7414001 act artic e1 hip brg 22x36mm.G2: foreign: new zealand.The customer has indicated that the product will not be returned to zimmer biomet for investigation as its location is unknown.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 underwent an initial hip procedure.Subsequently, the patient was revised approximately 10 months later due to loosening of the acetabular components.The primary x ray reportedly showed that the cup was never seated properly.Attempts have been made and no further information has been provided.

Manufacturer Narrative

No product was returned or pictures provided; visual and dimensional evaluations could not be performed.A review of the device history records identified no deviations or anomalies during manufacturing.Medical records/radiographs were provided and reviewed by a health care professional.A review of the available records identified findings of the reported issues: right total hip arthroplasty with likely loosening of the acetabular component and vertically oriented acetabular cup.A definitive root cause cannot be determined.The event is confirmed via medical reports of reviewed xray.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 information at the time of this report.

• Brand Name: G7 SCREW 6.5MM X 25MM
• 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: 18334127
• MDR Text Key: 330592559
• Report Number: 0001825034-2023-02973
• Device Sequence Number: 1
• Product Code: PBI
• UDI-Device Identifier: 00880304527461
• UDI-Public: (01)00880304527461(17)321123(10)7394616
• Combination Product (y/n): N
• Reporter Country Code: NZ
• PMA/PMN Number: K121874
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/03/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2023
• 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: 010000998
• Device Lot Number: 7394616
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/01/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/23/2022
• 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): Required Intervention; Hospitalization
• Patient Age: 77 YR
• Patient Sex: Male