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

Model Number N/A

Device Problem Difficult to Insert (1316)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 11/17/2022

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: item number: 010000661, item name: g7 pps ltd acet shell 48c, item lot: 7234550.Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that during the operation, the acetabular contusion was ground to 47-48 and then the g7 cup of 48 was placed, the cup was cleaned with water and then the prosthesis e1 high side liner model c was put on, the director tapped during the operation and found that the g7 cup and the liner were still not locked, the liner could still be clamped out, after repeated checks, there was no problem and reminded the director of the force of tapping and the angle of striking the liner, the liner still could not be locked, after up to 10 minutes of repeated after repeated checks and cleanups for up to 10 minutes, the liner still could not be locked.Due to the patient's bone quality, after the final discussion of the results, the ceramic liner model c was dismantled and struck in at once, and the shank part was finally implanted to complete this surgery.The result of this incident: the director questioned the locking mechanism and quality of this product, which prolonged the operation and made the patient bleed.As a result, the patient required a blood transfusion.

Event Description

There is no update to the original complaint description provided.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated updated: b4, g3, g6, h2, h3, h6, h10.Visual examination of the provided pictures identified no visible damage or defect on the liner.Review of the device history record(s) identified no deviations or anomalies during manufacturing.Device is used for treatment.The reported products were reviewed for compatibility with no issues noted.Review of complaint history identified additional similar complaints for the reported item(s) and no additional complaints for the reported part and lot combination(s).Complaints are monitored through monthly complaint review in order to identify potential adverse trends.Medical records were not provided.A definitive root cause cannot be determined.No corrective actions, preventive actions, or field actions resulted after investigation of this event.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

There is no update to the original complaint description provided.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Visual examination of the returned product identified scratching on both the inner and outer radii.The outer radius is also scuffed.The barb exhibits deformation from nicks and dings.Tool marks are present in the side wall.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 32MM C
• Type of Device: PROSTHETIC, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 15971514
• MDR Text Key: 305382225
• Report Number: 0001825034-2022-02763
• Device Sequence Number: 1
• Product Code: PBI
• UDI-Device Identifier: 00880304527010
• UDI-Public: (01)00880304527010(17)270403(10)7231439
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K121874
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 01/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2022
• 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: 010000925
• Device Lot Number: 7231439
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/27/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/03/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10.
• Patient Outcome(s): Other; Hospitalization
• Patient Age: 74 YR
• Patient Sex: Female
• Patient Weight: 49 KG