MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 HI-WALL ARCOMXL LNR 32MM F; PROSTHESIS, HIP

Model Number N/A

Device Problem Difficult to Insert (1316)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 05/11/2023

Event Type  Injury  

Manufacturer Narrative

(b)(4); d10: cat# 103530 lot# 323100 ti low profile screw 6.5x15mm; cat# 103531 lot# 449390 ti low profile screw 6.5x20mm.G2: foreign: mexico multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2023 - 01286 0001825034 - 2023 - 01287 the 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

It was reported that the patient underwent a hip procedure.It was during the surgical procedure that the doctor tried to place the insert inside the acetabular cup, impacting it so that it would remain inside the cup.The liner did not insert correctly.During the procedure, the doctor impacted several times and with force, the 36mm f insert, which was initially the one that was intended to be placed, but it did not go down correctly.The doctor saw that something was wrong and decided to open the 32mm f insert to try to place it.It was after several strong impacts that it did not enter the acetabulum correctly either and since the patient began to bleed, he decided to suspend the procedure.Attempts have been made and no further information has been provided.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.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/radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: the doctor tried to place the insert 32 f and failed to fit it into the acetabular cup and then tried with the insert 36 f but it was not inside the acetabular cup 56 f.After several attempts impacting the insert on the cup he gave up and opted instead to remove the prosthesis they were trying to put on the patient, leaving the hip hanging.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

No further information at the time of this report.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were {updated/corrected} updated: g3; h2.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: lateral plate and screw fixation device involving the proximal femur with radiolucency in between the plate and bone, nonspecific.Possible radiolucency along the femoral stem could indicate loosening.Spacing in between the lateral plate and the proximal femur lateral cortex could be intentional or could relate to loosening was identified.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

No further information is available at the time of this report.

• Brand Name: G7 HI-WALL ARCOMXL LNR 32MM F
• 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: 17073338
• MDR Text Key: 316640449
• Report Number: 0001825034-2023-01285
• Device Sequence Number: 1
• Product Code: PBI
• Combination Product (y/n): N
• Reporter Country Code: MX
• 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: 09/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 010000811
• Device Lot Number: 6956810
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/25/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2021
• 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 Sex: Male