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

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Bone Fracture(s) (1870); Unspecified Infection (1930)

Event Date 05/22/2023

Event Type  Injury  

Event Description

It was reported patient underwent a revision procedure 41 days post implantation due to an acetabular fracture and infection.The cause of the acetabular fracture is unknown; however, it is possible it occurred during the initial surgery.Reconstruction of the acetabular fracture was performed along with revision of the g7 cup and liner.No additional information is available.

Manufacturer Narrative

(b)(4).Cat# 110031011 lot# 65501813 28mm i.D.42mm o.D.Size e bearing.Cat# 650-1158 lot# 3136880 delta cer fem hd 28/0mm t1.Foreign: country: netherlands.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

There is no update to the prior event description provided.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated/corrected updated: visual examination of the returned product identified the inner radius of the shell has visible scratches and scuffing.The liner has porous indented into the poly along with other indentations.The installed head has visible wear.Complaint confirmed based on evaluation of returned product.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: interval development of a right acetabular periprosthetic fracture with increased vertical angulation of the acetabular cup.The acetabular cup is loose and has changed in position following fracture as noted with increased vertical cup angulation.A definitive root cause cannot 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 PPS LTD ACET SHELL 52E
• Type of Device: PROTHESIS, 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: 17009730
• MDR Text Key: 316007255
• Report Number: 0001825034-2023-01202
• Device Sequence Number: 1
• Product Code: PBI
• UDI-Device Identifier: 00880304524224
• UDI-Public: (01)00880304524224(17)330208(10)7440474
• Combination Product (y/n): N
• Reporter Country Code: NL
• 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: 08/31/2023

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?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 010000663
• Device Lot Number: 7440474
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/22/2023
• Initial Date FDA Received: 05/26/2023
• Supplement Dates Manufacturer Received: 08/30/2023
• Supplement Dates FDA Received: 09/06/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/08/2023
• 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): Required Intervention; Hospitalization
• Patient Sex: Prefer Not To Disclose