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

Model Number N/A

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Joint Dislocation (2374)

Event Date 08/03/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: 11-107021, freedom constr hd 36mm t1 +9mm, 172080, 110010263, g7 osseoti multihole 50mm d.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2018-04280.Customer has indicated that the product will not be returned to zimmer biomet for investigation, [remains implanted].The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that the patient's right hip is to be revised 3 months post implantation due to dislocation.No further information was made available.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Reported event was confirmed by review of x rays.Radiograph review: initial ap pelvis view shows anatomic alignment of the right hip arthroplasty components.Subsequent ap view of the right hip superolateral dislocation of the prosthetic femoral head and constraining ring.Device history record (dhr) was reviewed and no discrepancies relevant to the reported event 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.

Manufacturer Narrative

This follow-up report is being submitted to relay additional and corrected information.

Event Description

It was reported that the patient's right hip is being considered for revision 5 months post implantation due to dislocation.No revision has been reported to date.Attempts to obtain additional information have been made; however, no more is available at this time.

• Brand Name: G7 FREEDOM CONST E1 LNR 36MM D
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 7654331
• MDR Text Key: 112852745
• Report Number: 0001825034-2018-04278
• 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: company representative,consum
• Type of Report: Initial,Followup,Followup
• Report Date: 10/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/02/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 09/02/2020
• Device Model Number: N/A
• Device Catalogue Number: 010000982
• Device Lot Number: 3624468
• Other Device ID Number: (01) 0 0880304 52852 9
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/03/2018
• 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: 45 YR
• Patient Weight: 61