MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 10 DEG E1 LINER 36MM E; PROSTHESIS, HIP

Model Number N/A

Device Problems Off-Label Use (1494); Device Dislodged or Dislocated (2923)

Patient Problem Joint Dislocation (2374)

Event Date 11/11/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant products: cat# 110010244 g7 osseoti 3 hole shell 52mm e lot#6964449; cat# 52.34.0688 mathys head (competitor) lot# 2276691; cat# 010000999 g7 screw 6.5mm x 30mm lot#6817834; unknown mathys stem (competitor).Report source: foreign country: (b)(6).The device will not be returned for analysis, as the device was discarded; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.

Event Description

It was reported that the patient underwent another revision surgery approximately 5 months later due to recurrent dislocations.It is noted that competitor products were used with zimmer biomet products during the last revision.Attempts have been made and additional information on the reported event is unavailable at this time.

Event Description

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

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.Radiographs were provided and reviewed by a health care professional.Review of the available records identified potentially under sized acetabular cup for the size of the femoral head.In the appropriate clinical context, this could account for recurrence dislocations.Review of the device history records identified no deviations or anomalies during manufacturing.It was identified that zimmer biomet devices were implanted with competitor devices.Zimmer biomet has not confirmed the compatibility for these combinations of devices.It is unknown if these off-label usages may have caused or contributed to the reported events.A definitive root cause could not 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 10 DEG E1 LINER 36MM E
• 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: 12916789
• MDR Text Key: 281598675
• Report Number: 0001825034-2021-03260
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 00880304526761
• UDI-Public: (01)00880304526761(17)250303(10)6760350
• 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: 03/28/2022

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: 010000896
• Device Lot Number: 6760350
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/11/2021
• Initial Date FDA Received: 12/02/2021
• Supplement Dates Manufacturer Received: 03/28/2022
• Supplement Dates FDA Received: 03/29/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/03/2020
• 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
• Patient Sex: Female
• Patient Weight: 80 KG