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

Model Number N/A

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Joint Dislocation (2374); Subluxation (4525)

Event Date 12/26/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Year of birth - (b)(6).Concomitant medical device: 32mm mod head cocr -3mm neck # item 163668, lot raj6245267; g7 pps ltd acet shell 50d # item 010000662, lot 6258286; echo por fmrl nc 11x135mm # item 192011, lot 842650.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2019-01076.Report source: (b)(6).Clinical study: gh33 g7 acetabular cup with echo bi metric stem in tha.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.

Event Description

It was reported that the patient suffered right hip luxation and dislocation while she was leaning over a table in seated position and underwent closed reduction under sedation with an overnight hospital stay approximately eleven days post initial surgery.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

Udi - (b)(4).Reported event was unable to be confirmed due to limited information received from the customer.Device history record was reviewed and no discrepancies relevant to the reported event were found.Root cause was 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.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated/corrected updated: b4; b5; b7; g3; h2; h6 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.

Event Description

No additional event information to report at this time.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.The additional medical records provided; medical records were provided and reviewed by a health care professional.Review of the available records identified the following: hip luxation while patient was leaning over table in a seated position.Closed reduction with sedation the additional information does not change the outcome of the previous investigation 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 NEUTRAL E1 LINER 32MM D
• 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: 8407622
• MDR Text Key: 138369698
• Report Number: 0001825034-2019-01077
• Device Sequence Number: 1
• Product Code: PBI
• UDI-Device Identifier: 00880304526341
• UDI-Public: (01)00880304526341(17)20200111(10)3502958
• 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,Followup,Followup
• Report Date: 10/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/11/2020
• Device Model Number: N/A
• Device Catalogue Number: 010000848
• Device Lot Number: 3502958
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/17/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/11/2015
• 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): Hospitalization; Required Intervention
• Patient Age: 69 YR
• Patient Sex: Female
• Patient Weight: 74 KG