MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 PPS LTD ACET SHELL 50D; PROSTHESIS, HIP

Model Number N/A

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

Patient Problems Bone Fracture(s) (1870); Pain (1994); Ambulation Difficulties (2544)

Event Date 06/06/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant products: cat# 30103604 g7 vit e neutral lnr 36mm d lot# 65052206; cat# 00877503604 biolox⮠delta, ceramic femoral head, xl, 㸠36/+7, taper 12/14 lot# 3052293; cat# 574202030 avenir cmpl ha ho col size 3 lot# 3044581.Customer has indicated that the product will not be returned to zimmer biomet for investigation.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: 0001822565 - 2021 - 01782.

Event Description

It was reported that the patient underwent a right hip arthroplasty approximately 1 month ago and was revised on an unknown date due to a femoral and acetabular periprosthetic fractures.No falls or traumatic events were reported.No additional information.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.

Event Description

It was reported the patient underwent a right hip revision approximately 1 week post implantation due to femoral and acetabular periprosthetic fractures from a fall.The cup remained intact.All other components were replaced without complication.No additional information.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.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: nondisplaced periprosthetic right proximal femur fracture; right acetabular fracture which extends into anterior inferior iliac spine, posterior superior acetabular roof, and likely into the right pubic root, small osseous fragment along the posterior inferior margin of the acetabulum adjacent to the acetabular cup.Patient was doing well until 4 days prior to ed arrival complained of worsening right hip pain and difficulty bearing weight prompting ed visit, diagnosed with ppfx, no evidence of dvt.Denies falls or recent trauma since her surgery but does report having difficulty getting onto her bed, which may have precipitated this event.No evidence of gross purulence or infection, loose femoral component, well-fixed and well-positioned acetabular component, hip abductors intact.Patient fell and sustained a periprosthetic femur fracture around the femoral stem; this was an early postoperative fracture so the stem was not ingrown.Loosening not called out as it is a result of the fall/fracture, and not enough time has passed for ingrowth to take place.Limb lengthening planned to reduce risk of instability.Cup left in place, all other components revised without complication 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.

• Brand Name: G7 PPS LTD ACET SHELL 50D
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 12085759
• MDR Text Key: 258955879
• Report Number: 0001825034-2021-01915
• Device Sequence Number: 1
• Product Code: PBI
• Combination Product (y/n): N
• PMA/PMN Number: K121874
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: study
• Type of Report: Initial,Followup,Followup
• Report Date: 09/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 010000662
• Device Lot Number: 6966419
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/31/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10 NARRATIVE
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Weight: 81