MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 NEUTRAL E1 LINER 36MM G; HIP PROSTHESIS

Model Number N/A

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Joint Dislocation (2374)

Event Date 04/22/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation, due to remaining in the patient.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Concomitant medical products: 650-1057, cer bioloxd option hd 36mm, 2907287, 193014, echo b-mtrc mp fp so 14, 785800, 010000666, g7 pps ltd acet shell 58g, 6232582.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2018 - 04197.

Event Description

It was reported that patient suffered dislocation approximately 3 weeks post implantation.Patient was reaching for something on the floor while sitting on a low stool.Dislocation was corrected with closed reduction with the patient under general anesthesia.No additional patient consequences were reported.

Manufacturer Narrative

This follow-up report is being submitted to relay corrected and additional information.(b)(4).Reported event was confirmed by review of medical records.Device history record (dhr) was reviewed and no discrepancies relevant to the reported event were found.Investigation results concluded that the reported event was due to the fact the patient flexed the hip so much that the head dislocated from the liner.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 NEUTRAL E1 LINER 36MM G
• Type of Device: HIP PROSTHESIS
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 7629374
• MDR Text Key: 112021296
• Report Number: 0001825034-2018-04196
• 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,health
• Type of Report: Initial,Followup
• Report Date: 08/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 02/01/2023
• Device Model Number: N/A
• Device Catalogue Number: 010000859
• Device Lot Number: 6227063
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/03/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 53 YR
• Patient Weight: 132