MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 BONEMASTER LTD ACET SHL 50D; PROSTHESIS, HIP

Model Number N/A

Device Problems Corroded (1131); Material Erosion (1214); Detachment of Device or Device Component (2907); Unintended Movement (3026)

Patient Problem Pain (1994)

Event Date 01/28/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).Report source: foreign: (b)(6).It is unknown at this time if the device will be returned for analysis, due to location of device is unknown; however, an investigation of the reported event is in progress.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: 0001825034-2021-00323.

Event Description

It was reported that the patient underwent a revision procedure approximately 3 years post implantation due to the fracture of the liner and disassociation from the shell causing the ceramic head to rub onto the g7 shell.Attempts have been made and additional information on the reported event is unavailable at this time.

Event Description

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

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.D10: catalog#: 010000926 g7 hi-wall e1 liner 32mm d lot#: 3602595.Catalog#: 650-1163 delta cer fem hd 32/-3mm t1 lot#: 2016120766.Unknown stem.

Event Description

Upon reassessment of the reported event, the cup was determined to be not reportable.The initial report was forwarded in error and should be voided.

Manufacturer Narrative

Upon reassessment of the reported event, the cup was determined to be not reportable.The initial report was forwarded in error and should be voided.

• Brand Name: G7 BONEMASTER LTD ACET SHL 50D
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11274494
• MDR Text Key: 230120079
• Report Number: 0001825034-2021-00322
• Device Sequence Number: 1
• Product Code: PBI
• Combination Product (y/n): N
• PMA/PMN Number: K121874
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 06/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 010000702
• Device Lot Number: 6007375
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/25/2021
• Initial Date FDA Received: 02/03/2021
• Supplement Dates Manufacturer Received: 02/02/2021; 06/10/2021
• Supplement Dates FDA Received: 02/26/2021; 06/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: HIP-OTHER-HEADS-UNK; HIP-OTHER-LINERS-UNK; HIP-OTHER-STEMS-UNK; SEE H10 NARRATIVE; HIP-OTHER-HEADS-UNK; HIP-OTHER-LINERS-UNK; HIP-OTHER-STEMS-UNK
• Patient Outcome(s): Hospitalization; Required Intervention