MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 HI-WALL E1 LINER 36MM E; PROSTHESIS, HIP

Model Number N/A

Device Problem Fracture (1260)

Patient Problems Failure of Implant (1924); Local Reaction (2035)

Event Date 04/10/2021

Event Type  Injury  

Event Description

It was reported by the patients legal counsel that the patient underwent an initial left replacement surgery.Over a year later, the patient underwent a revision surgery of the head and liner.The head allegedly showed signs of wear from contact with the metal shell and modest metallic soft tissue.The liner was found showing complete rupture of the locking mechanism with no other signs of failure.

Manufacturer Narrative

(b)(4).Age or dob: 1966.Concomitant medical products: item #: unknown, head lot #: unknown, item #: unknown, stem lot #: unknown, item #: unknown, cup lot #: unknown.Foreign: (b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation.The product location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

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 following sections were reported event was unable to be confirmed.Device history record (dhr) review was unable to be performed as the item and lot number of the device involved in the event is unknown.Root cause could not 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.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.D10: catalog number:650-0836 lot number:3033134 brand name: delta ceramic head, catalog number:110010244 lot number:6882116 brand name: g7 shell, catalog number:51-137090 lot number:3975819 brand name: tprlc 133 mp 12.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.

Event Description

No additional event information to report at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Review of the device history record(s) identified no deviations or anomalies during manufacturing.The additional information does not change the outcome of the previous investigation.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 36MM E
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 14074743
• MDR Text Key: 289004139
• Report Number: 0001825034-2022-00865
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 00880304527102
• UDI-Public: (01)00880304527102(17)250820(10)6848102
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K121874
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 09/06/2022

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: 010000935
• Device Lot Number: 6848102
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/31/2022
• Initial Date FDA Received: 04/11/2022
• Supplement Dates Manufacturer Received: 04/19/2022; 05/04/2022; 08/30/2022
• Supplement Dates FDA Received: 05/05/2022; 05/31/2022; 09/06/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Female