MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 ACETABULAR LINER; PROSTHESIS, HIP

Model Number N/A

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Pain (1994); Joint Dislocation (2374); Ambulation Difficulties (2544); Subluxation (4525)

Event Date 12/03/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Year of birth: (b)(6).(b)(4).Concomitant medical products: 163668, raj6245267, 32mm mod head cocr -3mm neck; 010000662, 6258286, g7 pps ltd acet shell 50d; 192011, 842650, echo por fmrl nc 11x135mm.Foreign country: (b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation, due to the device remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports.

Event Description

It was reported patient suffered hip dislocation and subluxation approximately 5 months post implantation after turning in bed.Patient underwent closed reposition under sedation to correct the malfunction.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.Reported event was confirmed by review of x-rays and medical records reviewed by a health care professional.Review of the available records identified dislocation and subluxation requiring closed repositioning under sedation.Two previous complications of dislocation/subluxation were noted.Device history record (dhr) was reviewed and no discrepancies 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.

Event Description

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

Event Description

It was reported that the patient underwent right hip arthroplasty.Subsequently, the patient experienced multiple recurrent dislocations/subluxations.The patient was treated with reposition/reduction under sedation.The patient was later revised approximately one year post implantation due to the multiple reoccurring dislocations.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Review of medical records received confirms dislocation and subluxation requiring closed repositioning under sedation.Two previous complications of dislocation/subluxation were noted.Medical records for the revision were not received.X-rays were provided and reviewed by a health care professional.No abnormal findings were noted in the review.There was no radiolucency, the femoral stem is intact, no acute fracture.Acetabular inclination angles were provided: right hip 53 degrees, left hip 43 degrees.Device history record (dhr) was reviewed and no discrepancies 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 report 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.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

It was reported that the patient underwent right hip arthroplasty approximately one year post implantation due to the multiple reoccurring dislocations.During the procedure, the head and liner were removed and replaced.The stem and shell remained implanted.

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.Additional medical records provided; medical records were provided and reviewed by a health care professional.Review of the available records identified the following: problems with mobility, self-care; moderate pain and anxiety.Revision due to 5 luxation¿s of original implant.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 ACETABULAR LINER
• 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: 8908224
• MDR Text Key: 154879487
• Report Number: 0001825034-2019-03695
• Device Sequence Number: 1
• Product Code: PBI
• UDI-Device Identifier: 00880304526341
• UDI-Public: (01)00880304526341(10)3502958(17)200122
• 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,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 10/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/26/2020
• 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: 01/26/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Female
• Patient Weight: 74 KG