MAUDE Adverse Event Report: ZIMMER BIOMET, INC. BIOMET FEMORAL HEAD; HIP PROSTHESIS

Model Number N/A

Device Problem Detachment Of Device Component (1104)

Patient Problem No Code Available (3191)

Event Date 12/29/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Medical devices: item #11-165216 ringloc bipolar liner lot #084290.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2018-00509, 00510.

Event Description

It was reported that a patient underwent an initial hip procedure.Subsequently, the patient was revised approximately 4 months later due to disassociation.The liner separated from the femoral head.Attempts have been made, and no further information has been provided.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Complaint sample was evaluated and the reported event was not confirmed.Visual inspection found the head to be free of any major notable damage.A small amount of surface scratching and scuffing was observed on the outer radius.Dimensional analysis was performed and found to be within the print specifications.The shell, ring and liner remain assembled upon receipt.The locking ring can be seen in all 6 of the cutouts of the liner indicating that the liner is appropriately seated.Visual inspection found gouging on the rim of the liner.No notable damage was observed on the liner¿s inner radius.A small amount of wear was observed on the outer radius of the shell in the form of scuffing and scratches.Dhr was reviewed and no discrepancies relevant to the reported event were found.Root cause was unable to be determined.A summary of the investigation was sent to the complainant.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

It was reported that a patient underwent an initial hip procedure.Subsequently, the patient was revised approximately 4 months later due to disassociation.The liner separated from the femoral head.Attempts have been made, and no further information has been provided.

• Brand Name: BIOMET FEMORAL HEAD
• Type of Device: HIP PROSTHESIS
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 7241837
• MDR Text Key: 99069817
• Report Number: 0001825034-2018-00509
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK911684
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: N/A
• Device Catalogue Number: 163660
• Device Lot Number: 072390
• Other Device ID Number: (01) 0 0880304 25650 7
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/17/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/17/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/12/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 80 YR
• Patient Weight: 70