MAUDE Adverse Event Report: ZIMMER BIOMET, INC. HIP-G7-LINERS-UNK; PROTHESIS, HIP

Model Number N/A

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Pain (1994); Joint Dislocation (2374); Ambulation Difficulties (2544)

Event Date 02/04/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).D10: unknown g7 cup unk, unknown head unk, unk avenir stem.G2: foreign: italy.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2023-01633.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 bilateral hip arthroplasty.Subsequently, seven months post implantation, the patient had a right hip revision due to pain and dislocation.According to the legal complaint, the head and liner were exchanged.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated/corrected: b4, b5, g3, h2, h6.The reported event was able to be confirmed based on evaluation of medical records.No product was returned, no pictures, or device identification.Medical records identified that the patient had severe right hip pain and was prescribed anti-inflammatory therapy.They were recommended urgent prosthetic revision surgery after clinical exam and x-ray images showed an "appearance feeling of instability and yielding to the right." x-ray showed the prosthetic head had risen.The revision was performed due to allegations of dislocation.Device history records could not be reviewed due to lack of item and lot identification.A definitive root cause could not 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 additional information.

• Brand Name: HIP-G7-LINERS-UNK
• Type of Device: PROTHESIS, 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: 17334338
• MDR Text Key: 319276134
• Report Number: 0001825034-2023-01632
• Device Sequence Number: 1
• Product Code: PBI
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/17/2023
• 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: HIP-G7-LINERS-UNK
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/23/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 Age: 57 YR
• Patient Sex: Female