MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 HI-WALL E1 LINER 32MM D; PROSTHESIS, HIP

Model Number N/A

Device Problems Fracture (1260); 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: 0001825034-2021-00322.

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.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.D10: catalog#: 010000702 g7 bonemaster ltd acet shl 50d lot#: 6007375.Catalog#: 650-1163 delta cer fem hd 32/-3mm t1 lot#: 2016120766.Unknown stem.

Event Description

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

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.The event was confirmed with medical records and radiographs received.Review of the available records, identified: g7/taperlock microplasty stem inserted in 2017.There were no postoperative complications from initial implant.Discomfort on and off worse in the preceding 2 weeks prior to the revision.Liner had dislocated inferiorly and slightly anterior out of the cup.There was black metal staining inside the capsule with little normal colour joint fluid, macroscopically not infected.The liner had broken a couple of segments from the inferior aspect of the high wall and that is the suspected reason for the repeated impingement.The cup itself was damaged by the hard ceramic head, but was well fixed and the orientation seemed correct and the stem was slid and left in situ.Patient is reasonably fit, although post op she had minor aki.Patient denied any trauma or fall contributing to this event.Device history record 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.

• Brand Name: G7 HI-WALL E1 LINER 32MM D
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11274492
• MDR Text Key: 230118453
• Report Number: 0001825034-2021-00323
• 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

• Date FDA Received: 02/03/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/02/2020
• Device Model Number: N/A
• Device Catalogue Number: 010000926
• Device Lot Number: 3602595
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: HIP-OTHER-CUPS-UNK.; HIP-OTHER-HEADS-UNK.; HIP-OTHER-STEMS-UNK.; SEE H10 NARRATIVE.; HIP-OTHER-CUPS-UNK; HIP-OTHER-HEADS-UNK; HIP-OTHER-STEMS-UNK
• Patient Outcome(s): Hospitalization; Required Intervention