MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 LONGEVITY 10DEG LNR 40MM F; PROSTHESIS, HIP

Model Number N/A

Device Problems Detachment of Device or Device Component (2907); Naturally Worn (2988)

Patient Problems Failure of Implant (1924); No Code Available (3191)

Event Date 12/22/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for the investigation as the product location is unknown.The investigation is in process and a follow-up mdr will be submitted upon completion.Multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2021 - 00159.

Event Description

It was reported that patient underwent a hip revision approximately 18 days post implantation due to the poly liner disengaging from the 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.The following sections were updated/corrected updated: g3; h2; h3; h6 radiographs were provided and reviewed by a third party hcp noting asymmetric position of the femoral head within the acetabular cup consistent with poly wear.No bony fracture is seen.Overall fit of the implants are good.Acetabular inclination angles cannot be accurately measured without a true ap pelvis film.Visually, the cup appears to be in appropriate position.Dhr was reviewed and no discrepancies were found.The root cause is 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.

Event Description

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

• Brand Name: G7 LONGEVITY 10DEG LNR 40MM F
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11170203
• MDR Text Key: 226801312
• Report Number: 0001822565-2021-00158
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• PMA/PMN Number: K190660
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup
• Report Date: 04/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/14/2021
• 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: 20114006
• Device Lot Number: 64802523
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: UNK SHELL.; UNK SHELL
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 49 YR