MAUDE Adverse Event Report: ZIMMER ORTHOPAEDIC MFG. LTD. G7 OSSEOTI ACETABULAR SHELL; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER

Catalog Number 110010245

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

Patient Problems Bone Fracture(s) (1870); Osteopenia/ Osteoporosis (2651)

Event Date 09/29/2022

Event Type  Injury  

Manufacturer Narrative

(b)(4).D10: item# 31-323230; lot# 035260.Item# 110010267; lot# 7169626.Item# 00625006535; lot# j7149845.Item# 00625006535; lot# j6845219.Item# 00625006525; lot# j7279725.Item# 00625006525; lot# j7310878.Item# 30104007; lot# 65502244.Item# 650-1058; lot# 3105785.Item# 650-1067; lot# 3103935.Item# 51-107120; lot# 7076019.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Medical records were not provided.Review of the device history record(s) identified no deviations or anomalies during manufacturing.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.

Event Description

It was reported that the bilateral patient underwent an initial right hip arthroplasty approximately one (1) year and four (4) month ago.During the initial implantation, the patient's pelvis fractured.Subsequently, the patient was later revised approximately seven (7) months post-implantation to receive a pmi device due to the pelvic fracture from the initial implantation and limited bone stock.Attempts have been made and no further information has been provided.

• Brand Name: G7 OSSEOTI ACETABULAR SHELL
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER
• Manufacturer (Section D): ZIMMER ORTHOPAEDIC MFG. LTD.; building no 2 east park; shannon industrial estate; shannon, county clare ; EI
• Manufacturer (Section G): ZIMMER ORTHOPAEDIC MFG. LTD.; building no 2 east park; shannon industrial estate; shannon, county clare ; EI
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 19116455
• MDR Text Key: 340283226
• Report Number: 3007963827-2024-00095
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 00887868355899
• UDI-Public: (01)00887868355899(17)320712(10)65575792
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K140669
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/16/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 110010245
• Device Lot Number: 65575792
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/05/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/18/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: NI
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Female