MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 BONEMASTER LTD ACET SHL 58G; PROSTHESIS, HIP

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Loss of Range of Motion (2032)

Event Date 12/01/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).Report source: (b)(6).Concomitant products: catalog number:110024465 lot number:082030 brand name: g7 dual mobility liner.Catalog number:010000706 lot number:7013950 brand name: g7 bonemaster ltd shell.Catalog number:51-117130 lot number:6992376 brand name: tprlc 133 mp type1 bm.Catalog number: 650-1159 lot number:3066346 brand name: delta cer fem hd 28/-3mm t1.Multiple reports were submitted along with this report 0001825034-2022-01173, 0001825034-2022-01175.Customer has indicated that the 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.Remains implanted in the patient.

Event Description

It was reported that the patient had to have steroids injection for hip pain and stiffness approximately 4 weeks post implantation.Attempts have been made and additional information on the reported event is unavailable.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Medical records/radiographs were provided and reviewed by a health care professional.A review of the available records identified findings of the reported issues 4 weeks post op patient reported lateral hip pain, hip stiffness.No other complications were noted.Reported event was confirmed by review of medical records provided.Review of the device history records identified no (related) deviations or anomalies during manufacturing.Root cause could not be determined as the necessary information to adequately investigate the reported event was not provided.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 event information available at the time of this report.

• Brand Name: G7 BONEMASTER LTD ACET SHL 58G
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 14310632
• MDR Text Key: 290950577
• Report Number: 0001825034-2022-01174
• Device Sequence Number: 1
• Product Code: PBI
• UDI-Device Identifier: 00880304524651
• UDI-Public: (01)00880304524651(17)310429(10)7013950
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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
• Report Date: 05/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/06/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 010000706
• Device Lot Number: 7013950
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/16/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/29/2021
• 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
• Patient Outcome(s): Other; Hospitalization
• Patient Sex: Male
• Patient Weight: 87 KG