MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 NEUTRAL E1 LINER 32MM G; PROSTHETIC, HIP

Model Number N/A

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Joint Dislocation (2374); Subluxation (4525)

Event Date 12/01/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: item #: 163669, item name: 32mm mod head cocr std neck, lot number: 00j3600508, item #: 192015, item name: echo por fmrl nc 15x155mm, lot number: 534880, item #: 010000667, item name: g7 pps ltd acet shell 60g, lot number: 3441508, unk lot unk apical plug.Report source: foreign: denmark.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2023-00036.The device will not be returned for analysis as it remains implanted; however, an investigation of the reported event is in progress.Once the investigation is completed, as supplemental medwatch will be submitted device remains implanted.

Event Description

It was reported that after the patient had an initial right total hip arthroplasty the patient experienced dislocation and subluxation resulting in closed repositioning.No further compilations have been reported and the patient remains very satisfied with his new joint at this time.There is no additional information available at the time of this report.

Manufacturer Narrative

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.Liner - review of the device history record(s) identified no deviations or anomalies during manufacturing related to the reported event.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: dislocation and subluxation, closed repositioning on (b)(6) 2021.No issues, pain, or discomfort on (b)(6) 2022.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.

Event Description

There is no update to the previous event description provided.

• Brand Name: G7 NEUTRAL E1 LINER 32MM G
• Type of Device: PROSTHETIC, 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: 16112607
• MDR Text Key: 306803974
• Report Number: 0001825034-2023-00037
• Device Sequence Number: 1
• Product Code: PBI
• Combination Product (y/n): N
• Reporter Country Code: DA
• 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: 02/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/31/2019
• Device Model Number: N/A
• Device Catalogue Number: 010000851
• Device Lot Number: 3387421
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/01/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 69 YR
• Patient Sex: Male