MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 PPS LTD ACET SHELL 48C; PROSTHETIC, HIP

Model Number N/A

Device Problem Difficult to Insert (1316)

Patient Problems Bone Fracture(s) (1870); Hemorrhage/Bleeding (1888)

Event Date 07/20/2023

Event Type  Injury  

Manufacturer Narrative

(b)(4).D10: 010000665 g7 pps ltd acet shell 56f, lot#: 7045029.010000858 g7 neutral e1 liner 36mm f, lot#: 6804756.010000925 g7 hi-wall e1 liner 32mm c, lot#: 7273194.010000660 g7 pps ltd acet shell 46b, lot#: 7325368.010000924 g7 hi-wall e1 liner 32mm b, lot#: 7244680.00-6250-065-20 trilogy bone scr 6.5x20, lot#: 65776795.00-6250-065-30 trilogy bone scr 6.5x30, lot#: 65135477.00877503601 biolox⮠delta, ceramic femoral head, s, 㸠36/-3.5, taper 12/14, lot#: 3087631.0100101920 wagner sl revision⮠hip stem, uncemented, 㸠20/190, taper 12/14, lot#: 3119806.G2: foreign: china.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2023-01888, 0001825034-2023-01889, 0001825034-2023-01891, 0001825034-2023-01894, 0001825034-2023-01894.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.H3 other text: device in process to return.

Event Description

It was reported on that during a procedure, an unknown event causing left femoral fracture in a patient with history of previous left femoral neck fracture and moderate anemia with no report of previous tha.During the surgery encountered ebl 1500 ml due to patients left inter-rotor fracture combined with the old fracture of neck of femur, and the local soft tissue edema and adhesion, that caused a lot of bleeding during the operation.Patient was transfused with 9 units of rbc and 950 ml of ffp during the extended surgical repair of fracture.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.

Event Description

It was reported that during a procedure, an unknown event caused a left femoral fracture in a patient with history of previous left femoral neck fracture and moderate anemia with no report of previous tha.Initially, the surgeon was unable to seat the 46 acetabular cup and liner and then they replaced the cup and liner with a size 48 acetabular cup and liner which resulted in cracking the acetabulum when they hit the liner.Subsequently, the patient encountered estimated blood loss of 1500 ml due to the patients left inter-rotor fracture combined with the old fracture of neck of femur, and the local soft tissue edema and adhesion.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.Visual inspection of the returned device shell 7359351 had no visible damage.Complaint confirmed based on medical records and evaluation of returned products.Review of complaint history identified additional similar complaints for the reported item(s) and part and lot combination(s).Complaints are monitored through monthly complaint review in order to identify potential adverse trends.Medical records/radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: left femoral intertrochanteric fracture, old fracture of the left femoral neck, cause of left lower extremity edema: microcirculation obstruction in the left lower extremity, moderate anemia.Acetabulum fracture was lax, posterior lower edge was defective, and unstable, repaired with a 7 hole plate and screws.There was a lot of bleeding during the operation, intraoperative bleeding of about 1500 ml and reinfused during the operation.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

There is no update to the prior event description provided.

• Brand Name: G7 PPS LTD ACET SHELL 48C
• 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: 17558722
• MDR Text Key: 321310961
• Report Number: 0001825034-2023-01890
• Device Sequence Number: 1
• Product Code: PBI
• UDI-Device Identifier: 00880304524200
• UDI-Public: (01)00880304524200(17)321020(10)7359351
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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,Followup
• Report Date: 09/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/16/2023
• 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: 010000661
• Device Lot Number: 7359351
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/20/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/20/2022
• 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; Hospitalization
• Patient Age: 81 YR
• Patient Sex: Female
• Patient Weight: 55 KG