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

Model Number N/A

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Joint Dislocation (2374)

Event Date 11/23/2019

Event Type  Injury  

Event Description

It was reported a patient had an initial right hip total arthroplasty.Subsequently, the patient experienced a dislocation approximately 3 years later due to a fall.The hip was successfully reduced with moderate sedation.Attempts have been made and no further information has been provided.

Manufacturer Narrative

(b)(4).D10: cat# 650-1057 lot# 537390 cer bioloxd option hd 36mm; cat# 110017103 lot# 3841407 g7 finned 3 hole shell 52e; cat# 650-1065 lot# 329700 cer option type 1 tpr sleve -3; cat# 51-103090 lot# 3880920 tprlc 133 type1 pps so 9x137mm.The customer has indicated that the product will not be returned to zimmer biomet for investigation as it remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

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.Medical records/radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: x-ray: in good position, no radiolucent lines, no osteolysis, good bony ingrowth.Patient was bending over and felt her hip pop.Successful reduction of dislocation under moderate sedation.X-ray: dislocated right tha, no evidence of fracture, left hip is aligned.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.

• Brand Name: G7 NEUTRAL E1 LINER 36MM E
• 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: 18452294
• MDR Text Key: 332184267
• Report Number: 0001825034-2024-00035
• Device Sequence Number: 1
• Product Code: PBI
• UDI-Device Identifier: 00880304526426
• UDI-Public: (01)00880304526426(17)211101(10)3915013
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121874
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/01/2021
• Device Model Number: N/A
• Device Catalogue Number: 010000857
• Device Lot Number: 3915013
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/21/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2016
• 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: 86 KG
• Patient Race: White