MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 FREEDOM CONST E1 LNR 36MM G; PROSTHESIS, HIP

Model Number N/A

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Joint Dislocation (2374)

Event Date 08/16/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: 11-107020, freedom constr hd 36 mm t1 + 6 mm, 55130.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2018-06028.Customer has indicated that the product will not be returned to zimmer biomet for investigation, [product location unknown].The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported a patient's left hip was revised approximately one month post implantation due to dislocation.Patient revised (b)(6) 2017 due to recurrent dislocation, components all removed.Hematoma found and removed during this procedure.No further information is available at this time.

Manufacturer Narrative

This report is being submitted to relay additional information.(b)(4).The following sections have been corrected: corrected lot number of associated device.Concomitant medical products: 11-107020, freedom constr hd 36mm t1 +6mm, 55130.Reported event was confirmed with the review of operative notes.Device history record (dhr) was reviewed and no discrepancies were found.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.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: G7 FREEDOM CONST E1 LNR 36MM G
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 7752136
• MDR Text Key: 116085696
• Report Number: 0001825034-2018-06015
• Device Sequence Number: 1
• Product Code: PBI
• Combination Product (y/n): N
• PMA/PMN Number: PK121874
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,study
• Type of Report: Initial,Followup
• Report Date: 10/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/06/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/08/2019
• Device Model Number: N/A
• Device Catalogue Number: 010000985
• Device Lot Number: 3476107
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/14/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 56 YR
• Patient Weight: 59