MAUDE Adverse Event Report: ZIMMER TMT TRABECULAR METAL ACETABULAR REVISION SHELL; PROSTHESIS, HIP

Model Number	N/A
Medical Device Problem Code	Unstable (1667)
Health Effect - Clinical Codes	Pain (1994); Scar Tissue (2060); Swelling/ Edema (4577)
Date of Event	08/27/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device was discarded by the facility.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported the patient underwent left tha due to femoral neck fracture.Subsequently, patient was revised two days later due to an iatrogenic acetabular fracture.The patient underwent a second revision approximately 4 months later due to pain and instability with placement of a custom cage and constrained liner.During the revision, significant scarring was noted which prompted the removal of the femoral component.The acetabular component was found well fixed and ingrown.The cemented liner was removed as well as the cup.Backing out the screws was not possible, so the surgeon cut them with a bur so that the custom cage could be placed.Due to intraoperative complications, only the custom cage, liner, and screws were placed.The wound was closed without femoral components in place, and the patient was transferred to the critical care unit.Attempts have been made and additional information on the reported event is unavailable at this time.
Additional Manufacturer Narrative
No product was returned; visual and dimensional evaluations could not be performed.Review of the device history record(s) identified no deviations or anomalies during manufacturing.Medical records were provided and reviewed by a health care professional.Noted from the initial total hip arthroplasty and first revision: poor bone quality, bone fracture that occurred during the primary tha, inability to obtain good construct for a total hip arthroplasty, and had to convert to hemiarthroplasty indicating a revision procedure would be likely.One month post op visit: presents with pain 7/10, instability, catching, swelling, pain with activities, radiating pain.Left hip exam - acetabular cup failure with gross movement and loss of inferior bony contact.Plan to revise with custom cage.Four month post op visit: patient has been non-weightbearing for 4 months waiting for custom cage to be manufactured, continues to have pain and inability to walk.2nd revision: significant scarring noted; femoral component was revised, no complications.Acetabular liner removed, however this was cemented into the acetabular component and acetabular component was well fixed into the acetabulum at this point, despite it failing with it being more horizontal in position.The trabecular metal had grown well into the bone.The cage, screws, and constrained liner were replaced.During reduction, bleeding noted from the sciatic notch region, hemostasis agents packed in to control bleeding, 'i removed the packing and there was less bleeding noted already, however at the same time that this was occurring anesthesia notified me that the patient was dropping her blood pressure and ekg rhythm was not detectable.This was approximately 3 hours into surgery.They requested supine position for chest compressions.For this reason hip was left dislocated i then placed ___ over the incision and the chest compressions were started along with resuscitative measures.' patient stabilized with return of arterial pulses and spontaneous eye opening, vascular surgeon consulted.Surgeon felt the amount of bleeding that was present was not abnormal for pelvic veins, bleeding was subsiding once packing was removed.'vascular surgery performed arterial and venous studies and felt no vascular injury was present.' patient stabilized well enough to proceed with wound closure, manipulation of the joint and reduction was too risky.Femoral component removed, no bleeding noted, wound closed.Patient left or in critical condition to icu intubated, limb well-perfused.Ebl 1000ml, complications cardiac arrest and asystole.Custom cage with screws and liner remained in the patient, no femoral components.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 or Problem Description
No further event information available at the time of this report.

• Brand Name: TRABECULAR METAL ACETABULAR REVISION SHELL
• Common Device Name: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER TMT; 10 pomeroy road; parsippany NJ 07054
• Manufacturer (Section G): ZIMMER TMT; 10 pomeroy road; parsippany NJ 07054
• Manufacturer Contact: christina arnt ; 10 pomeroy road; parsippany, NJ 07054 ; 9735760032
• MDR Report Key: 12697114
• Report Number: 3005751028-2021-00066
• Device Sequence Number: 19944682
• Product Code: JDI
• UDI-Device Identifier: 00889024310902
• UDI-Public: (01)00889024310902(17)230630(10)63959491
• Combination Product (Y/N): N
• Initial Reporter State: NM
• Initial Reporter Country: US
• PMA/510(K) Number: K003181
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/07/2022

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2023
• Device Model Number: N/A
• Device Catalogue Number: 00700006220
• Device Lot Number: 63959491
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/01/2021
• Supplement Date Received by Manufacturer: 01/07/2022
• Initial Report FDA Received Date: 10/26/2021
• Supplement Report FDA Received Date: 01/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/28/2018
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Female
• Patient Weight: 63 KG