MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN G7 CUP; PROTHESIS, HIPS

Model Number N/A

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Migration (4003)

Patient Problems Pain (1994); Deformity/ Disfigurement (2360); Unequal Limb Length (4534); Insufficient Information (4580)

Event Date 09/21/2023

Event Type  Injury  

Manufacturer Narrative

(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported the patient underwent an initial right hip arthroplasty on an unknown date.Subsequently, the patient plans to be revised due to an unknown reason.Attempts have been made and no further information has been provided.

Event Description

It was reported a patient had a revision of a right hip prosthesis.Subsequently, approximately two weeks later, radiographic imaging displayed dissociation of the cup from the pelvis and ¿huge¿ pelvic defects.Upon follow-up, the patient reports having severe pain and assessment indicated that the right leg was shortened.A pmi product is currently being planned for the patient¿s next revision.

Manufacturer Narrative

This follow-up report is being submitted to relay additional and/or corrected information.Investigation codes updated.Investigation summary results remain unchanged and no new information to report at this time.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

No additional event information to report at this time.

Event Description

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

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Reported event was confirmed by review of radiographs.Review of the available records identified the following:xrays show displaced cup from recent surgery and the cup is disassociated  from the acetabulum.  bone quality is severely osteopenic which could contribute to this complication.There is no evidence of trauma ct showed dissociation of pelvis.  her leg is neurovascular intact, shortened on right side.Large pelvic defect, with high pain.Device history record (dhr) 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.

• Brand Name: UNKNOWN G7 CUP
• Type of Device: PROTHESIS, HIPS
• 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: 17995377
• MDR Text Key: 326375523
• Report Number: 0001825034-2023-02475
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K140669
• 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,Followup,Followup,Followup
• Report Date: 03/14/2024
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 10/24/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: UNKNOWN G7 CUP
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/12/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2018
• 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): Other
• Patient Age: 62 YR
• Patient Sex: Female
• Patient Weight: 107 KG