MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 OSSEOTI MULTIHOLE 58MM G; PROTHESIS, HIP

Model Number N/A

Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problem Bone Fracture(s) (1870)

Event Date 04/03/2024

Event Type  Injury  

Manufacturer Narrative

(b)(4).A2: date of birth: information provided by the hospital showed the date of birth documented as two different dates: (b)(6) 1947 and (b)(6) 1948.D10: cat# 010000985 lot# 7648566 g7 freedom const e1 lnr 36mm g.Cat# 11-107021 lot# 884560 freedom constr hd 36mm t1 +9mm.Cat# 010000997 lot# 7681145 g7 screw 6.5mm x 20mm.Cat# 010000997 lot# 7641778 g7 screw 6.5mm x 20mm.Cat# 010000999 lot#7665793 g7 screw 6.5mm x 30mm.Cat# 010000999 lot# 7633835 g7 screw 6.5mm x 30mm.Cat# 010000999 lot# 7648566 g7 screw 6.5mm x 30mm.G2: foreign: country: australia.Product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that the patient had a right total hip arthroplasty on an unknown date.The patient had a right hip revision approximately one month ago due to recurrent dislocations.Subsequently, the patient was revised approximately a weeks ago due to a pelvic fracture which led to cup loosening.It was reported that the pelvic fracture was thought to have occurred in the previous revision.No additional information available.

• Brand Name: G7 OSSEOTI MULTIHOLE 58MM G
• 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: 19097091
• MDR Text Key: 340032853
• Report Number: 0001825034-2024-01005
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 00887868356056
• UDI-Public: (01)00887868356056(17)340111(10)66390801
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K140669
• 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
• Report Date: 04/12/2024

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: 110010267
• Device Lot Number: 66390801
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/02/2024
• Initial Date FDA Received: 04/12/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/11/2024
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Sex: Female