MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ACT ARTIC E1 HIP BRG 28X40MM; PROSTHESIS, HIP

Model Number N/A

Device Problems Detachment of Device or Device Component (2907); Device Dislodged or Dislocated (2923)

Patient Problems Ossification (1428); Pain (1994); Scar Tissue (2060); Joint Dislocation (2374)

Event Date 12/03/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 -2019 -05735, 0001825034 -2019 -05737.

Event Description

It was reported the patient underwent right tha.Subsequently, patient suffered a dislocation approximately 8 months later and was treated with unsuccessful closed reduction.Right revision was performed 2 days later due to the dual mobility bearing had dissociated from the biolox head.Extensive scar tissue, heterotopic ossification surrounding acetabulum component was noted.Difficulty with seating of head/liner, removed and performed additional debridement and was able to place liner and reduce hip without further issues.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.D4: udi#(b)(4).Reported event was confirmed with medical records provided.Review of the available records identified the following: revision due to right hip dislocation w/dissociation of dual mobility construct & atrophic scar.Extensive scar tissue removed.Scar tissue around poly femoral head.Notes fascia was not approximated and was able to probe to joint level ¿specimens sent (no results provided).No necrosis or purulence.Stem well fixed.Heterotopic ossification & stiff scar tissue around acetabulum.Removed liner, found acetabular component well fixed.Liner seated and was cemented inplace.Attempted to reduce hip, unable to seat, would not lock.Multiple attempts.Removed the new liner and cement and found additional scar tissue needed debrided new liner cemented and was able to reduce patient.Complex procedure, 3 hrs to complete.Review of the device history records 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 28X40MM
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9519317
• MDR Text Key: 173163883
• Report Number: 0001825034-2019-05736
• Device Sequence Number: 1
• Product Code: KWY
• 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: 04/13/2020

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 Expiration Date: 12/12/2023
• Device Model Number: N/A
• Device Catalogue Number: EP-200146
• Device Lot Number: 820680
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/11/2019
• Initial Date FDA Received: 12/26/2019
• Supplement Dates Manufacturer Received: 04/09/2020
• Supplement Dates FDA Received: 04/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: BIOMET LINER CAT#110024462 LOT#359580; BIOMET SHELL CAT#010000662 LOT#6387774; ZIMMER HEAD CAT#00877502801 LOT#2962146; ZIMMER STEM CAT#00786401300 LOT#64052372
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Weight: 64