MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 BONEMASTER LTD ACET SHL 52E; PROSTHESIS, HIP

Catalog Number 010000703

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

Patient Problems Failure of Implant (1924); Metal Related Pathology (4530)

Event Date 06/02/2023

Event Type  Injury  

Manufacturer Narrative

(b)(4).G2: france.D10: cat #: 110003634 / biolox delta cer lnr 36mm e / lot #: 3127962 cat #: 650-0660 / delta ceramic fem hd 36/-3mm / lot #: 3130619.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch will be submitted.

Event Description

It was reported a patient underwent a right hip revision approximately eight months¿ post implantation due to aseptic loosening of the acetabulum.During the procedure, tissue with metallosis was removed.The shell, head and liner were removed and replaced.Attempts have been made and no further information is available.

Manufacturer Narrative

(b)(4).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.Medical records/radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: traces of metallosis found samples sent to path.Acetabulum found retroverted and horizontal.¿there is clear mobility, but not easily removed¿ microscopically examination revealed bone integration on surface of component.X-ray review found there is radiolucency along the acetabular implant which could be associated with implant loosening but on the images provided no loosening is identified.Metallosis cannot be confirmed on these images.Complaint confirmed based on the evaluation of the medical records.Dhr was reviewed and no discrepancies related to the reported event were found.A definitive root cause is unable to 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 additional event information to report at this time.

• Brand Name: G7 BONEMASTER LTD ACET SHL 52E
• 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: 17319548
• MDR Text Key: 319019572
• Report Number: 0001825034-2023-01572
• Device Sequence Number: 1
• Product Code: PBI
• UDI-Device Identifier: 00880304524620
• UDI-Public: (01)00880304524620(17)321002(10)7345186
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K121874
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 010000703
• Device Lot Number: 7345186
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/18/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/02/2022
• 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 Age: 72 YR
• Patient Sex: Female
• Patient Weight: 72 KG