MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 OSSEOTI 3 HOLE SHELL 50MM D; PROSTHESIS, HIP

Model Number N/A

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Failure of Implant (1924)

Event Date 08/14/2023

Event Type  Injury  

Manufacturer Narrative

(b)(4).D10: cat# 00-8775-036-02 lot# 3144560 biolox delta head 12/14 36x0.Cat# 00-7713-007-00 lot # 65672923 mod ml taper fem st 7.5.Cat# 00-6250-065-15 lot# j7356065 trilogy bone scr 6.5x15.Cat# 00-6250-065-20 lot# j7448932 trilogy bone scr 6.5x20.Cat# 00-6250-065-40 lot # 63684496 trilogy bone scr 6.5x40.G2: foreign: japan.The customer has indicated that the product will not be returned to zimmer biomet for investigation as it remains implanted.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 underwent an initial hip surgery.Approximately four months later, the patient underwent a revision due to dissociation of the liner.Attempts have been made and no further information has been provided.

Event Description

No further information at the time of this report.

Manufacturer Narrative

No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history record(s) identified no deviations or anomalies during manufacturing related to the reported event.Medical records were not provided.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 OSSEOTI 3 HOLE SHELL 50MM D
• Type of Device: PROSTHESIS, 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: 17897400
• MDR Text Key: 325247859
• Report Number: 0001825034-2023-02287
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 00880304544185
• UDI-Public: (01)00880304544185(17)320822(10)65513123
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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,Followup
• Report Date: 11/16/2023

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?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 110010243
• Device Lot Number: 65513123
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/21/2023
• Initial Date FDA Received: 10/09/2023
• Supplement Dates Manufacturer Received: 11/16/2023
• Supplement Dates FDA Received: 11/22/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/05/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10 NARRATIVE.
• Patient Outcome(s): Hospitalization; Required Intervention