MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 PPS LTD ACET SHELL 52E; PROSTHETIC, HIP

Model Number N/A

Device Problem Positioning Failure (1158)

Patient Problem Foreign Body In Patient (2687)

Event Date 11/06/2023

Event Type  Injury  

Manufacturer Narrative

(b)(4).D10: 00625006535 item name bone scr 6.5x35 self-tap lot # j7475826.G2: foreign: canada.The device will not be returned for analysis as it remains implanted; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch will be submitted.

Event Description

It was reported that while inserting the screw through the cup, the screw proceeded through the screw hole in the cup and into the acetabulum.Unsure if the screw head is too small or the screw hole is too big as the screw is unable to be retrieved for inspection.There is no additional 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 updated/corrected.Updated: b4.G3.G6.H2.H6.H10.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Complaint confirmed based on the evaluation of the provided medical records.Review of the device history record(s) identified no deviations or anomalies during manufacturing related to the reported event radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: right hip acetabular cup from a tha with a screw that has penetrated the cup fully seated within the bone.The root cause of the reported issue is attributed to user error, as the surgeon did not use the gold drill guide during the procedure.Per g7 surgical technique use the dual angle drill guide to drill a pilot hole in the desired screw hole.Make certain the drill guide is fully seated and locked into position within the screw hole before the drill bit begins to engage bone.This will ensure the appropriate screw direction can be achieved.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 prior event description provided.

• Brand Name: G7 PPS LTD ACET SHELL 52E
• 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: 18231686
• MDR Text Key: 329316038
• Report Number: 0001825034-2023-02793
• Device Sequence Number: 1
• Product Code: PBI
• UDI-Device Identifier: 00880304524224
• UDI-Public: (01)00880304524224(17)321207(10)7400303
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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
• Report Date: 03/20/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/29/2023
• 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: 010000663
• Device Lot Number: 7400303
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/18/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/07/2022
• 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: PLEASE SEE H10
• Patient Outcome(s): Other
• Patient Sex: Prefer Not To Disclose