MAUDE Adverse Event Report: . G7 NEUTRAL; PROSTESIS, HIP

Catalog Number 010000848

Device Problem Positioning Failure (1158)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/08/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Concomitant medical products: part#:unknown/unknown, g7 shell, lot #: unknown.Part#: unknown/unknown taperlock stem, lot#: unknown.Part#: unknown/unknown head, lot#: unknown.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2019-05171.

Event Description

It was reported that during surgery surgeon was unable to seat the liner in the shell after numerous attempts.No additional patient consequences were reported.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

Reported event was able to be confirmed by visual inspection.Visual examination of the returned liner identified damage to the locking feature.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.

• Brand Name: G7 NEUTRAL
• Type of Device: PROSTESIS, HIP
• Manufacturer (Section D): .; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9423854
• MDR Text Key: 206879555
• Report Number: 0001825034-2019-05486
• 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: distributor
• Type of Report: Initial,Followup
• Report Date: 04/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 010000848
• Device Lot Number: 6509350
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/29/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 67 YR