MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 NEUTRAL E1 LINER 32MM F; PROSTHESIS, HIP

Model Number N/A

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

Patient Problems Unspecified Infection (1930); Pain (1994); Ambulation Difficulties (2544)

Event Date 09/13/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Concomitant medical products: part: 010000664, lot: 3633648, g7 pps ltd acet shell 54f.Part: 192010, lot: 933560, echo por fmrl nc 10x130mm.Part: 163669, lot: 00j3600506, 32mm mod head cocr std neck.Report source:(b)(6).Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2021-02820, 0001825034-2021-02823, 0001825034-2021-02822.

Event Description

It was reported a patient underwent an initial left total hip arthroplasty and subsequently, the patient developed progressive pain, difficulty ambulating, and difficulties with adls.X-rays showed loosening of the acetabular cup.All components were revised 6 years post-implantation due to deep infection.Attempts have been made and no further information has been provided.

Manufacturer Narrative

Reported event was confirmed due to the review of medical records.Medical records/radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: the patient underwent initial hip arthroplasty and no complications were noted.The patient was revised and identified moderate pain and was unable to tie shoes on a 3-month visit.There was moderate pain on a 1-year visit.There was moderate pain, tying shoes with difficulty, and moderate difficulties with adls on a 2-year visit.There was moderate pain and moderate to extreme difficulties with adls on a 5-year visit.X-rays indicates cup loosening.Revised on indication of deep infection.Device history record (dhr) was reviewed and no discrepancies were found.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 event information available at the time of this report.

• Brand Name: G7 NEUTRAL E1 LINER 32MM F
• 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: 12577727
• MDR Text Key: 274776224
• Report Number: 0001825034-2021-02824
• Device Sequence Number: 1
• Product Code: PBI
• UDI-Device Identifier: 00880304526365
• UDI-Public: (01)00880304526365(10)3453516(17)191029
• Combination Product (y/n): N
• Reporter Country Code: DA
• PMA/PMN Number: K121874
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/28/2021

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/29/2019
• Device Model Number: N/A
• Device Catalogue Number: 010000850
• Device Lot Number: 3453516
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/20/2021
• Initial Date FDA Received: 10/05/2021
• Supplement Dates Manufacturer Received: 12/27/2021
• Supplement Dates FDA Received: 12/29/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/29/2014
• 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
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 72 YR
• Patient Sex: Female
• Patient Weight: 90 KG