MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ACT ARTIC E1 HIP BRG 28X44MM; PROSTHESIS, HIP

Model Number N/A

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Pain (1994); Loss of Range of Motion (2032); Scar Tissue (2060); Swelling (2091); Joint Dislocation (2374); Blood Loss (2597)

Event Date 09/18/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical devices: zimmer cat#00-8775-028-01 lot# 2993959 na biolox delta fem head, 28mm, -3.5mm; zimmer cat#00-7711-011-10 lot#63622660 na m/l taper 11 std reduced neck length; biomet cat#110024464 lot#891800 g7 dual mobility acetabular liner.The device will not be returned for analysis due to the device being discarded; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental mdr will be submitted.

Event Description

It was reported a patient underwent right tha.Subsequently, patient was revised approximately 7 months later due to recurrent dislocations.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

This follow-up report is being submitted to relay additional information.Medical records/radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: follow up visit, notes pain 8/10, swelling, notes dislocation episode 2 weeks post op treated with a closed reduction.Concerned with lucency noted around cup.X-rays demonstrate the stem may have subsided a little bit but difficult to tell based on orientation of x-ray.Chronically dislocated right total hip arthroplasty, attempted revision with conversion to girdlestone arthroplasty.Scar tissue removed from femoral neck and head.Pseudocapsule removed.Attempted to reduce the trunnion into the cup but were easily 2cm or more from accomplishing this.After removing scar tissue from femur and acetabulum, surgeon felt to remove more tissue would have required skeletonizing the proximal femur and removing abductors which he was hesitant to do as it may remove reasonable function.Iliopsoas was removed on initial surgery, therefor a girdlestone arthroplasty commenced.Significant bleeding throughout case as all tissues were irritable and bleeding copiously.Acetabular component remained well fixed and left in place to avoid further blood loss.Review of the device history record(s) identified no deviations or anomalies during manufacturing.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.

• Brand Name: ACT ARTIC E1 HIP BRG 28X44MM
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10650138
• MDR Text Key: 210447819
• Report Number: 0001825034-2020-03713
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• PMA/PMN Number: K101336
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup
• Report Date: 12/09/2020

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
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: EP-200150
• Device Lot Number: 885430
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/25/2020
• Initial Date FDA Received: 10/08/2020
• Supplement Dates Manufacturer Received: 12/08/2020
• Supplement Dates FDA Received: 12/10/2020
• 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: 69