MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 ACETABULAR LINER; PROSTHESIS, HIP

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problems Cellulitis (1768); Pain (1994); Swelling (2091)

Event Date 10/13/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).(b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation, due to device remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2018 - 09329, 0001825034 - 2018 - 09332, 0001825034 - 2018 - 09337.

Event Description

It was reported patient was diagnosed with cellulitis approximately two months post implantation after experiencing right hip swelling and pain.The patient was treated with medication.There was no surgery intervention.Attempts have been made and additional information on the reported event is unavailable.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.(b)(4).Reported event was unable to be confirmed due to limited information received from the customer.Device history record was reviewed and no discrepancies relevant to the reported event 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.

Event Description

No further event information available at the time of this report.

• Brand Name: G7 ACETABULAR LINER
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 7934088
• MDR Text Key: 122662984
• Report Number: 0001825034-2018-09335
• 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: foreign,health professional,s
• Type of Report: Initial,Followup
• Report Date: 11/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2019
• Device Model Number: N/A
• Device Catalogue Number: 010000936
• Device Lot Number: 3433293
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/17/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: 010000704 3689499 G7 BONEMASTER LTD ACET SHL 54F; 51-199341 448710 SIRIUS HIP STEM 44-D; 650-0661 2016031392 DELTA CERAMIC FEM HD 36/0MM; 010000704 3689499 G7 BONEMASTER LTD ACET SHL 54F; 51-199341 448710 SIRIUS HIP STEM 44-D; 650-0661 2016031392 DELTA CERAMIC FEM HD 36/0MM
• Patient Outcome(s): Required Intervention
• Patient Age: 58 YR
• Patient Weight: 82